1260 Regulatory Affairs Jobs - Page 6

As an Associate Regulatory Affairs, your primary role will be to assist in obtaining and maintaining regulatory approvals for beauty, health, wellness, cosmetics, and food products. It is crucial to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs. Your responsibilities will include preparing dossiers that are country and category-specific for domestic and international markets to ensure error-free and timely submissions according to department timelines. You will be responsible for coordinating with suppliers and vendors to maintain product master data. Additionally, you will review, prepare, submit, and coordinate with relevant regulatory bodies across countries. Resolving deficiencies and queries from customers, partners, and regulatory agencies will also be part of your role. You will assist in the development of Regulatory Affairs Standard Operating Procedures (SOPs) and ensure adherence to internal audit requirements as per Quality Management System (QMS) standards. Participating in risk-benefit analysis for regulatory compliance and identifying, planning, and implementing process improvement initiatives are also key aspects of your responsibilities. To qualify for this role, you must hold a graduate degree in Science, Engineering, or Pharmacy. A minimum of 2 years of experience in global regulatory requirements of products, processes, and procedures is required. Experience in product compliance or product stewardship is preferred. You should be able to work independently without supervision and communicate effectively, both in writing and orally, with technical and non-technical colleagues. As a problem solver, you should be able to identify issues, review related information, develop and evaluate options, and implement effective solutions. Managing parallel projects and sometimes competing deliverables to meet project delivery dates will also be part of your job scope.,

As a Senior Regulatory Affairs Associate at our organization, you will play a crucial role in managing regulatory documentation, resolving technical queries from clients, and supporting vendor qualification processes. With a solid background in the Pharma raw material industry, particularly in excipient products, you will leverage your expertise to ensure compliance with regulatory standards and guidelines. Your responsibilities will include handling all regulatory documents related to excipients, addressing technical queries from pharmaceutical clients, managing technical matters and documentation for excipient manufacturers, and preparing technical documents for the promotion of excipient products. Additionally, you will be expected to provide specific technical documents for manufacturer and product qualification, manage regulatory qualification documents and queries, and coordinate with overseas excipient manufacturers. To excel in this role, you should possess good technical knowledge regarding guidelines, GMP, and testing methods for excipients, along with experience in vendor management. A minimum of 2+ years of experience in a regulatory and data role, as well as team management experience, is required. Candidates with a background in Pharma and experience in team handling will be given preference. This position offers competitive remuneration and benefits, and if you believe you have the necessary skills and experience to succeed in this role, we encourage you to apply. We look forward to connecting with you and potentially welcoming you to our team at CLYZO.,

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager, Global Regulatory Intelligence The Manager in the Global Regulatory Intelligence team is a hands-on contributor responsible for gathering and organizing regulatory intelligence under the guidance of the RI Director. This role often has a technology and data focus , managing the tools and information that drive the intelligence process. Key Responsibilities: Intelligence Gathering & Analysis: Assist in monitoring and analyzing the global regulatory landscape, and in developing intelligence reports and updates as directed by the RI Director. A core duty is to collect and synthesize new or updated local regulatory requirements obtained from Amgen s local regulatory teams, for the Manager s assigned areas of responsibility. This information feeds into the group s centralized knowledge base. The Manager helps execute the regulatory intelligence workplans by preparing agreed deliverables for example, compiling monitoring reports, bulletins, and landscape summaries that highlight regulatory changes or requirements relevant to upcoming filings. They ensure that these deliverables are coherent and actionable, providing clear recommendations or insights where appropriate . Tools & Data Management: Take ownership of the tools, databases, and documentation that support intelligence gathering and dissemination. The Manager is responsible for facilitating and maintaining these systems on a day-to-day basis. This includes ensuring that repositories of regulatory requirements and intelligence reports are up-to-date and accessible to stakeholders. Importantly, the Manager may also be expected to build or modify new tools and databases as needed, not just use existing ones. (For example, if a new tracking database or dashboard is required to capture regulatory changes, the Manager would play a key role in its development or configuration.) Emphasizing this in the job description sets clear expectations that the role involves technical initiative in improving intelligence systems. Cross-Functional Support: Work closely with other members of the Regulatory Policy & Intelligence team and with regulatory staff in various functions to ensure intelligence is applied effectively. The Manager engages with policy analysts, product regulatory leads, and other cross-functional team members to share findings and gather input. While the Manager may not lead cross-functional projects independently, they support these efforts by providing the necessary data or analysis. For instance, if a cross-product regulatory strategy project is underway, the Manager might supply the compiled country requirements or recent regulatory changes needed for decision-making. They help ensure that agreed intelligence deliverables are executed on time and that any intelligence requests from internal stakeholders are addressed promptly. Progress Tracking & Improvement: Monitor the progress of intelligence-gathering activities against the team s objectives and timelines. The Manager tracks their assignments (e.g., monitoring tasks or updates due) and regularly reports status to the RI Director. If there are delays or obstacles in obtaining information, the Manager flags these and helps troubleshoot solutions. Additionally, the Manager contributes to process improvement discussions identifying any inefficiencies in how intelligence data is collected or shared and suggesting enhancements. They participate in continuous improvement of the function s processes and tools, helping to refine workflows for greater efficiency and reliability. Knowledge & Skills: Regulatory Knowledge: A solid grounding in regulatory affairs processes and requirements is needed. The Manager should understand regulatory submission guidelines and procedures across different regions (major markets and smaller markets) and have familiarity with how local regulations impact drug development and filings. While they may rely on senior staff for deeper analysis, the Manager must be able to interpret regulatory documents or health authority guidance and extract key points. The ability to handle complex information and distill it into clear summaries is crucial often the Manager will be the first to review new regulations and must highlight what matters to Amgen s products. Attention to Detail and Analytical Skills: The role requires strong analytical abilities and attention to detail. The Manager will be dealing with regulatory texts, tracking changes, and inputting data into intelligence systems so accuracy is paramount. They should be skilled at comparing regulatory requirements and spotting differences or trends. At the same time, they need to maintain a big-picture view to recognize how a particular change might affect Amgen s global filing strategy. Being able to propose practical solutions or escalate important findings is part of this analytical skill set. Technical and Project Skills: Proficiency in using information systems and databases is important, as this role often acts as the power user of regulatory intelligence tools. Experience with managing or configuring databases, spreadsheets, or tracking tools will be useful. The Manager should also have good project coordination skills capable of managing their own workstreams, meeting deadlines, and juggling multiple intelligence requests or projects. Strong written and oral communication skills are needed to draft clear reports and to communicate findings to the team or other stakeholders. Additionally, a willingness to learn and even create new technical solutions (e.g., leveraging an internal SharePoint site or an intelligence software platform) is highly valued in this position. Qualifications: Education & Experience: It is recommended that candidates have at least a Bachelor s degree in a relevant discipline (such as life sciences or regulatory affairs) plus relevant experience in regulatory or drug development roles. An advanced degree ( Master s or higher) in a related field is a plus. While Amgen s internal templates for similar roles have sometimes listed lower educational minima ( e.g. associate degree or high school with significant years of experience), for a Regulatory Intelligence Manager it is preferable to require a Bachelor s degree as the minimum qualification . This ensures the candidate has a sufficient foundation to grasp complex regulatory information. In terms of experience, a few years of hands-on regulatory affairs or regulatory operations experience (for instance, ~3-5 years with a Bachelor s degree ) would likely be expected, given the need to work independently and with understanding of the regulatory context. Preferred Background: Relevant industry experience in pharmaceutical/biotech regulatory affairs or compliance is strongly preferred. Experience specifically with regulatory intelligence or policy tracking whether in a prior role or via project work would allow a new hire to hit the ground running. Familiarity with regulatory intelligence tools or subscription databases (such as Tarius or similar services) and experience interacting with global regulatory colleagues would also be advantageous . The ideal candidate will be one who not only has the technical skills to manage data and tools, but also the curiosity and insight to understand why regulatory changes matter and how to communicate those insights effectively.

The MAC Reference Librarian will be responsible for managing the digital Reference Library and Match Text Library within the Veeva Global PromoMats system, while adhering to internal guidelines, SOPs (Standard Operating Procedures), policies and industry regulations. Roles & Responsibilities: Manage Reference and Match Text Libraries for multiple US MAC Teams Adding new Match Text records and adjusting existing records. Manage Amgen Label Reference documents in Veeva Organize annual reviews Supports Global Initiative/Other MAC related projects. Expert in MAC Reference Requirements and Veeva Reference & Annotation (R&A) technology. Performs Quality Check on all References uploaded into the Reference Library to ensure aligned to R&A requirements Builds & maintains strong relationships with project Sponsors (owners), Reviewers, agencies, and other MAC Cross functional partners while also providing training on Reference Library and Linking requirements & identify Reference QC issues Collaborates with Material Compliance Managers (MCM) to understand BU/Product business priorities and elevate process issues that arise Collaborates with MCA to identify and correct Reference QC issues Partners with SciComm to update Links to Reference Anchors in MAC materials Manage the MAC Reference Library email Inbox. Create and manage associated work instructions. Facilitate weekly Reference Library Office Hours Reports to the Director of Material Compliance in Regulatory Affairs Required Knowledge and Skills: Ability to foster collaboration, work effectively on cross-functional teams, and consistently deliver on-time. Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills. Critical thinking and problem-solving skills Quick learner, proactive, takes initiative. Distinguishes proper balance between strategic and tactical thinking. Strong experience with Project Management tools, methodologies, and practices Proven ability to manage in a highly fluid, interactive, matrix environment. Authoritative command of complexity and ambiguity, ability to see the big picture, ability to collect, digest and assemble information to enable relevant business analysis and influence decision-making. Identify continuous process and system improvements to save time and cost to Amgen. Preferred Knowledge and Skills: An understanding of the pharmaceutical commercialization process and knowledge of the legal and regulatory guidelines affecting promotion of prescription products Project management experience in the Pharmaceutical, Biotechnology or other Healthcare-related field, or other regulated industries Experience with Microsoft Office 365 (e.g. Word, Excel, Outlook, and PowerPoint), Adobe products (e.g. Adobe Photoshop, Illustrator, and Acrobat Pro), and Veeva PromoMats Experience managing medical reference support for marketing materials that are produced at high volumes. Experience managing digital library and medical references. Basic Education and Experience: Bachelor s degree and 6 years of related experience OR Associate s degree and 10 years of related experience Preferred Education and Experience: Bachelor s degree and 6 years of related experience Experience working in a Global Regulatory Affairs organization AIN working hours for this position: This position supports the Regulatory Promotion and Material Compliance activities serving Amgen s US Business Operations and thus the AIN working hours will need to be flexible with occasional overnight work time when needed to support product launches and new indications.

The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, post market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Master s degree OR Bachelor s degree and 1-2 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Associate s degree and 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR High school diploma / GED and 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Job Summary: Amgen is seeking a Manager, Regulatory Affairs CMC - Data Automation to shape the future of regulatory affairs by driving digital transformation and automation within CMC submissions. At Amgen, we are committed to innovation and excellence in regulatory science, offering a dynamic work environment where expertise in automation and AI can make a meaningful impact on regulatory efficiency and compliance. Join us in revolutionizing regulatory submissions through cutting-edge data automation! Key Responsibilities: Support the implementation of automation and digital tools to streamline regulatory CMC documentation and submission workflows. Assist in developing standardized templates and structured data formats for consistent and compliant submissions. Contribute to projects focused on the application of AI and structured content/data management (SCDM) for regulatory use cases. Coordinate with cross-functional teams, including Process Development, Quality, and Regulatory Affairs, to ensure alignment on automation and data standards. Monitor industry trends and guidance to maintain up-to-date knowledge on digital and regulatory innovations. Support the design and deployment of automated solutions for data extraction, conversion, and integration with regulatory platforms. Participate in training activities to expand internal capabilities in digital tools and regulatory data automation. Assist in regulatory interactions related to digital transformation, ensuring preparedness for engagement on evolving standards. Basic Qualifications: Doctorate degree OR Master s degree and 3 years of directly related experience OR Bachelor s degree and 5 years of directly related experience Experience managing and leading a team in a regulatory or compliance environment Preferred Qualifications: Degree in life sciences, digital or data science, biochemistry, or chemistry Experience leading global regulatory CMC submissions with knowledge of ICH guidance and global requirements Background or basic experience in digitalization, automation, software development Background in manufacturing, process development, quality control, or quality assurance Hands-on experience with Veeva Vault platforms and regulatory technology solutions. What we expect from you We are all different, yet we all use our unique contributions to serve patients. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas Oncology , Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Director, Global Regulatory Intelligence Team The Director leads the strategic development and execution of the Global Regulatory Intelligence (GRI) function, ensuring Amgen stays ahead of an evolving global regulatory landscape. This role defines the teams mission, sets priorities, leads cross-functional collaborations, and ensures high-impact intelligence is embedded into regulatory strategy across the enterprise. Key Responsibilities: Function Leadership & Vision: Establish and evolve the Regulatory Intelligence function, defining structure, staffing strategy, vendor/outsourcing model, and the technology roadmap to support global operations. Set the vision and oversee the execution of intelligence deliverables that enable accelerated, compliant global product filings and approvals. Strategic Regulatory Insight & Change Leadership: Lead development of strategic insights into global regulatory trends and changes. Translate intelligence into actionable internal guidance, influencing filing strategies, development plans, and Amgen s engagement with evolving regulatory expectations. Serve as senior advisor on emerging regulatory shifts, coordinating enterprise-level change response strategies. External Engagement: Build and maintain relationships with external regulatory intelligence networks, peer companies, industry associations, and regulatory agencies to enhance Amgen s proactive intelligence-gathering capabilities. Coordinate with Regulatory Policy and country affiliates to ensure early awareness of critical developments. Cross-Functional Integration: Partner with Global Regulatory Affairs, Regulatory CMC, Clinical, Safety, and Policy functions to integrate intelligence into product strategy, labeling, and lifecycle plans. Lead cross-functional initiatives where regulatory intelligence enables enterprise transformation (e.g., structured submissions, digital requirements). Team Management & Talent Development: Hire, develop, and lead a high-performing Regulatory Intelligence team (including direct reports and external partners). Set goals, manage performance, mentor staff, and build capabilities aligned with future-state regulatory operations. Define and oversee budget, resource allocation, and vendor management for the function. Operational Excellence & Innovation: Ensure efficient, scalable, and continuously improving intelligence operations. Drive the adoption of innovative tools, data analytics, and automation solutions to accelerate and enhance regulatory intelligence outputs. Knowledge & Skills: Regulatory Expertise: Deep knowledge of global regulatory systems and evolving frameworks across major and emerging markets. Experience identifying and interpreting high-impact regulatory changes and their implications for development, submission, and approval strategies. Strategic & Analytical Thinking: Demonstrated ability to connect regulatory developments with strategic business impacts. Able to assess ambiguity, provide direction under uncertainty, and influence cross-functional decisions. External Presence & Influence: Skilled in representing Amgen in industry forums and engaging with regulatory bodies. Able to distill complex global issues into clear, compelling messaging for senior stakeholders. Leadership & Communication: Proven leadership of cross-functional teams and direct staff. Strong ability to communicate complex regulatory concepts clearly and persuasively across senior, technical, and global audiences. Innovation & Operational Mindset: Experience with process optimization, digital tools, and knowledge management systems. Ability to modernize intelligence workflows using structured data and automation. Qualifications: Education: Doctorate degree and 4+ years of experience, or Master s degree and 15+ years, or Bachelor s degree and 16+ years in regulatory affairs, policy, intelligence, or a related field. Experience: Prior leadership experience in global regulatory intelligence, regulatory policy, or strategy. Strong track record of advising on and responding to regulatory change . Experience in leading cross-functional regulatory initiatives and managing high-performing teams. Familiarity with regulatory intelligence tools, subscription databases, and external benchmarking approaches. Preferred: Demonstrated success building or scaling regulatory intelligence capabilities. Experience interacting with global regulatory authorities and representing company positions externally. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease . Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Novo Medi Sciences seeks a Regulatory Affairs Manager with 10+ yrs exp. in ACTD/CTD dossiers for semi/non-regulated markets. Location: Dadar East, Mumbai. B Pharm/M Pharm. Must handle queries, submissions, product lifecycle, and lead a team

Career Category Regulatory Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager, Global Regulatory Intelligence The Global Regulatory Policy & Intelligence (GRPI) group at Amgen engages with regulators, industry associations, and other stakeholders externally, and internally it manages regulatory intelligence for GRAAS - monitoring, analyzing, and communicating regulatory requirements worldwide to enable fast, efficient global filings. The Senior Manager, as part of this team, plays a pivotal role in executing the regulatory intelligence function. Key Responsibilities: Regulatory Intelligence Deliverables: Contribute to the monitoring and analysis of the global regulatory landscape and develop agreed intelligence deliverables under the supervision of the Regulatory Intelligence Director. This includes producing regulatory intelligence outputs that enable timely and efficient product filings worldwide - for example, compiling summaries of country-specific regulatory requirements , analyzing recent or upcoming changes in regulations, and providing recommendations to teams on filing strategies that maximize speed and compliance. The Senior Manager is accountable for delivering these assigned intelligence outputs to a high standard of quality. Processes & Systems Ownership: Oversee the efficient operation of specific intelligence-gathering systems and processes . The Senior Manager may be responsible for maintaining and improving tools or databases used for monitoring regulations and for ensuring that intelligence monitoring, analysis, and communication processes run smoothly in their area of ownership. They work in partnership with colleagues across GRAAS to refine these systems and may evaluate opportunities for automation or outsourcing to improve efficiency. Regulatory Analysis & Strategy Input: Analyze regulatory trends across Amgen s global footprint, identifying differences and commonalities in submission requirements between regions or product types. Based on this analysis, recommend practical approaches to dossier content and preparation that will satisfy local requirements while enabling globally efficient submissions. The Senior Manager provides this strategic input to global and local regulatory teams to influence filing strategies and ensure alignment with intelligence insights. They also identify major impending regulatory changes and help plan for regulatory change management efforts across the business (providing input to any large regulatory change projects). Cross-Functional Collaboration: Develop trusted relationships with cross-functional colleagues - including Global and Local Regulatory Affairs teams, Regulatory CMC, Policy staff, and others - to integrate intelligence into regulatory strategy and decision-making. The Senior Manager engages GRAAS policy staff, product strategy leads, and other experts to help establish priorities for intelligence activities and to execute on agreed deliverables. They often lead or coordinate cross-product regulatory projects (such as analyses to support multiple product filings) under the direction of the RI Director. In doing so, they ensure that intelligence findings are translated into actionable strategies and that any recommendations for policy advocacy (to promote global harmonization of requirements, for example) are communicated to the relevant teams. Continuous Improvement: Engage in continuous improvement of Regulatory Intelligence processes. The Senior Manager monitors progress against intelligence workplans and objectives, and conducts regular reviews with the RI Director to report on outcomes. They propose and implement enhancements to tools, methodologies, and workflows to increase the effectiveness of intelligence gathering and dissemination. For instance, they might help refine how regulatory information is captured and shared, contribute to templating requirements for future automation projects, or update procedures in response to lessons learned. Knowledge & Skills: Regulatory Expertise: A strong foundation in regulatory affairs is required . The Senior Manager should have recent global filing experience and in-depth knowledge of regulatory agency guidelines and procedures across major and non-major markets. An understanding of local regulatory processes and how they impact global submissions is important. The role demands the ability to synthesize complex regulatory information (from disparate sources and regions) and distill it into clear, actionable insights and recommendations. Project Management & Communication: Excellent project management skills are needed to handle multiple intelligence projects and deliverables. The Senior Manager must be able to track tasks, meet deadlines, and coordinate input from various contributors. Strong presentation and interpersonal communication skills are essential in order to effectively communicate intelligence findings to stakeholders and to represent the intelligence function in cross-functional discussions. The ability to influence without direct authority (especially when recommending changes to regulatory strategy based on intelligence) is a key soft skill for this role. Technical and Process Skills: Preferred candidates will bring experience in systems management and process management , as the role involves working with databases/tools and improving processes for information gathering. Familiarity with knowledge management practices and change management principles is also beneficial - for example, knowing how to systematically capture regulatory knowledge and support teams through major regulatory changes. An innovative mindset toward leveraging technology (including potential use of AI tools for intelligence) is a plus, given Amgen s interest in future automation of submission-ready content. Qualifications: Basic Qualifications: A combination of advanced education and relevant experience in life sciences/regulatory affairs. For instance, a Doctorate degree in a related field with ~4+ years of experience, Master s degree with ~3+ years, Bachelor s degree with ~5+ years, Associate s degree with ~10 years, or even a high school diploma/GED with ~12 years of directly related experience could be considered acceptable minimums. (These ranges align with internal job level guidelines for a role at the Senior Manager level.) Preferred Experience: Relevant industry experience in biopharmaceutical regulatory affairs (especially in regulatory intelligence, policy, or strategy functions) is highly desirable. The ideal candidate will have a track record of successfully managing regulatory information or contributing to regulatory submissions across multiple regions. Experience working on cross-functional teams and exposure to regulatory policy development or external advocacy would be a plus for this role. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Ignitho Technologies (India) Pvt Ltd is looking for Lead - Senior Associate to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports Processing requisition and other business forms, checking account balances, and approving purchases Advising other departments on best practices related to fiscal procedures Managing account records, issuing invoices, and handling payments Collaborating with internal departments to reconcile any accounting discrepancies Analyzing financial data and assisting with audits, reviews, and tax preparations Updating financial spreadsheets and reports with the latest available data Reviewing existing financial policies and procedures to ensure regulatory compliance Providing assistance with payroll administration

Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines Preparing, Reviewing and Submitting Renewal Dossiers / Variations. Responding to queries raised by Regulatory authority of respective country. Preparing CAPA reports for the audit or market complaints. Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc. Coordinating & Arranging for the registration samples as per country guideline. Reviewing & Approving the Artworks (Text Content) Coordinating with FDCA Person for COPP & GMP and its legalization process. Updating all registration status records. Maintaining Retain Samples Records. Coordinating with customer for filing of dossier & getting it timely approval. SKILLS: Fluent in English. Good communication skills. Ability to work under pressure and to meet deadlines.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Gurgaon, Haryana, India Job Description: Required Qualification and Core Competencies for the role: 8-12 years of experience in regulatory affairs in medical device industry. Strong knowledge of Medical Device Rule 2017 Strong knowledge of Drugs and Cosmetics Act Knowledge in the international regulations of Medical Devices in US and EU Sound knowledge on Medical Device Quality Management System ISO 13485 Excellent proficiency with software tools Key responsibilities: Draft, review and submission of Regulatory filings (Re-registrations/ New Registrations/ Legal-Physical manufacturer transfer). Draft, review and submission of other Regulatory submissions (Query responses, Corrections fillings, miscellaneous notifications regarding post registration regulatory lifecycle management) for India and IB market in accordance with applicable regulations and relevant guidelines. Draft cover letters for Regulatory communications/ submissions depending on level of regulatory knowledge/expertise Update and live maintenance of business plan in SharePoint for assigned franchises/ licenses. Assist in the preparation of technical presentations/ meetings with regulator Ensures compliance with regulatory agency regulations and interpretations. Gathers and assembles information, prepares documents for New Product Applications/Renewal Applications/Change Notifications/Response to Regulatory Agencies questions in accordance with regulations and relevant guidelines Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations (Lifecycle management) Coordination with internal stakeholders ensuring compliant lifecycle management of responsible products/ franchises. Maintain the changes to the Regulations/Products/Sites and make necessary submission to maintain compliance to Country Regulations Attend applicable training sessions as well as complete mandatory on-line e University trainings and submit training records to the supervisor / Admin assistant and work as per the applicable SOPs and guidelines. Maintenance of RA database for the responsible franchises in MDRIM tool. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/other portals. Ensuring timely completion of assigned Quality issues/ Corrective Actions in ETS system. Creation and maintenance of Product Registrations request Form (PRRF) for any registration activities under responsible franchises/ licenses and Change Controls for any product discontinuation/ changes as per defined procedure. Ensuring timely completion of received change assessment within due timeline and provide feedback to source RA team through email/ other portal. Ensure on time archival of regulatory submission documents. Supporting Pharmacovigilance and artwork activities for biological products (if applicable) Control of regulated/ non-regulated products/ codes in RA gateway tool. Support with on-time inputs for monthly regulatory report. Participate in execution of Field Action (Product Recall, Distribution of Field Safety Alerts, etc.) and complete the assigned tasks in a timely manner Understand complaint & adverse event reporting responsibility and report such events within 24 hours of becoming aware. Conducting Regulatory Standard Management monthly meeting and keeping a track on action items identified.

ROLES & RESPONSIBILITY Develop regulatory strategies for new/existing products. Ensure compliance with local/international regulations (CDSCO, ISO, FDA). Prepare and submit regulatory submissions. Monitor regulatory developments and adjust strategies. Liaise with regulatory bodies and internal teams for compliance. Conduct audits and maintain up-to-date knowledge of regulatory requirements. Required Qualifications: Bachelor s degree in a scientific discipline. 2 to 3 years experience in regulatory affairs within the medical device industry. In-depth knowledge of CDSCO, ISO, FDA standards. Experience with regulatory submissions and medical device development. Excellent communication, organizational, and project management skills. Preferred Qualifications: Advanced degree (Master s/Ph.D.). Professional certification in regulatory affairs (RAC).

Exp in regulatory affair policy analysis or compliance within power sector will be responsible for managing & ensuring compliance with all applicable law regulation policies & tariff orders governing solar wind & hybrid renewable energy projects Required Candidate profile In-depth knowledge of India's electricity laws, regulatory frameworks (Electricity Act, 2003), energy policies, and environmental regulations at both central and state (Karnataka is mandatory) levels

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

About The Role We are seeking a detail-oriented and proactive Data Quality & Configuration Analyst to support and enhance our ERP , SAP , and ITSM systems. The ideal candidate will be responsible for managing data quality , BOM configuration , and ensuring compliance with regulatory frameworks and internal controls . This role involves close collaboration with IT support , logistics , production control , and quality management teams. Key Responsibilities: Maintain and improve data quality standards across ERP and SAP systems. Configure and manage BOM (Bill of Materials) and master data in alignment with business and regulatory requirements. Support SAP parameterization , SAP support , and ServiceNow-based ITSM processes . Ensure data consistency and integrity across logistics , production , and transportation modules. Collaborate with business process management (BPM) teams to align data with operational workflows. Monitor and enforce regulatory compliance , internal control , and conformity control standards. Participate in data audits , issue resolution , and problem management . Provide IT support for data-related issues and contribute to continuous improvement initiatives. Required Skills & Qualifications: Bachelors degree in Information Technology , Business Administration , or a related field. 24 years of experience in data management , ERP/SAP configuration , or IT support . Hands-on experience with: SAP (parameterization, support) ERP systems ServiceNow or other ITSM tools BOM and master data configuration Strong understanding of data quality , data standards , and regulatory frameworks . Excellent problem-solving, communication, and documentation skills. Preferred Qualifications: Experience in logistics , production control , or quality management environments. Familiarity with BPM tools , conformity control , and operational management practices. Knowledge of metrology or data governance frameworks is a plus.

We are looking for a skilled E-commerce Operations Manager to join our team at CSTE International, with 3-8 years of experience in the IT Services & Consulting industry. Roles and Responsibility Manage and oversee e-commerce operations for smooth and efficient functioning. Develop and implement strategies to enhance customer satisfaction and loyalty. Collaborate with cross-functional teams to achieve business objectives. Analyze market trends and competitor activity to identify growth opportunities. Ensure compliance with regulatory requirements and industry standards. Lead and motivate a team to achieve operational excellence. Job Requirements Proven experience in e-commerce operations management or a related field. Strong understanding of IT Services & Consulting principles and practices. Excellent leadership and communication skills. Ability to analyze data and make informed decisions. Strong problem-solving and strategic thinking skills. Experience with e-commerce platforms and technologies.

Role & responsibilities The Assistant Manager Regulatory Affairs will manage regulatory activities related to the manufacturing and global supply of pharmaceutical excipients, ensuring compliance with Indian regulations (Schedule M, Drugs & Cosmetics Act) and support for international registrations and customer requirements. The role also includes support for compliance with Food Regulations. Key Responsibilities: Regulatory Affairs India - Prepare and submit applications for Drug Manufacturing Licenses, site approvals, and product-related permissions to State FDA/CDSCO - Ensure full compliance with Schedule M (GMP) requirements for excipient manufacturing - Handle site master files, SOPs, validation documentation, and ensure audit readiness for Indian regulatory inspections - Coordinate with QA/QC, Production, R&D, Engineering, and SCM to ensure complete and accurate documentation for regulatory needs - Liaise with regulatory authorities (State FDA, CDSCO) for approvals, renewals, inspections, and responses - Maintain up-to-date records and documentation for regulatory compliances - Assist in preparation and review of product labels, artworks, and promotional materials as per regulatory norms - Monitor regulatory updates (e.g., CDSCO, IP) and coordinate internal implementation - Support customer audits and due diligence for regulatory compliance in domestic markets Export Support & International Regulatory - Coordinate with Pharmexcil, CDSCO, and State FDA for issuance and renewal of COPP, FSC, Written Confirmations, and product registrations - Provide regulatory documentation to support customer registrations in various countries (technical data, GMP certificates, COA, MSDS, etc.) - Ensure compliance with international pharmacopeias (USP/NF, BP, Ph. Eur.) - Support customer audits and due diligence for regulatory compliance in export markets Food Regulatory Compliance Support - Provide support for ensuring compliance with FSSAI and related food regulations Industry Representation - Represent the company in industry bodies for policy updates and industry consultations - Participate in technical committees, regulatory workshops, and forums to stay aligned with evolving regulations and standards - Engage in dialogue with regulatory agencies and industry peers to advocate for excipient-related concerns Key Skills & Competencies: - In-depth knowledge of Indian regulations, especially Schedule M, Drugs & Cosmetics Act & Rules - Familiarity with CDSCO portals (SUGAM), State FDA procedures, and GMP guidelines - Exposure to export documentation and regulatory requirements for excipient registration in global markets - Good understanding of IPEC guidelines, customer compliance expectations, and product stewardship - Strong documentation and communication skills for handling regulatory submissions and external audits

Message to applicants applying to work in the U.S. and/or Canada: When available, the salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. and/or Canada locations, not including equity or benefits. For non-sales roles the hiring ranges reflect base salary only; employees are also eligible to receive annual bonuses. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidates hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. or Canada hiring location. The recruiter can share more details about compensation for the role in your location during the hiring process. U.S. employees have access to quality medical, dental and vision insurance, a 401(k) plan with a Cisco matching contribution, short and long-term disability coverage, basic life insurance and numerous wellbeing offerings. Employees receive up to twelve paid holidays per calendar year, which includes one floating holiday (for non-exempt employees), plus a day off for their birthday. Non-Exempt new hires accrue up to 16 days of vacation time off each year, at a rate of 4.92 hours per pay period. Exempt new hires participate in Cisco s flexible Vacation Time Off policy, which does not place a defined limit on how much vacation time eligible employees may use, but is subject to availability and some business limitations. All new hires are eligible for Sick Time Off subject to Cisco s Sick Time Off Policy and will have eighty (80) hours of sick time off provided on their hire date and on January 1st of each year thereafter. Up to 80 hours of unused sick time will be carried forward from one calendar year to the next such that the maximum number of sick time hours an employee may have available is 160 hours. Employees in Illinois have a unique time off program designed specifically with local requirements in mind. All employees also have access to paid time away to deal with critical or emergency issues. We offer additional paid time to volunteer and give back to the community. Employees on sales plans earn performance-based incentive pay on top of their base salary, which is split between quota and non-quota components. For quota-based incentive pay, Cisco typically pays as follows: .75% of incentive target for each 1% of revenue attainment up to 50% of quota; 1.5% of incentive target for each 1% of attainment between 50% and 75%; 1% of incentive target for each 1% of attainment between 75% and 100%; and once performance exceeds 100% attainment, incentive rates are at or above 1% for each 1% of attainment with no cap on incentive compensation. For non-quota-based sales performance elements such as strategic sales objectives, Cisco may pay up to 125% of target. Cisco sales plans do not have a minimum threshold of performance for sales incentive compensation to be paid.

The ideal candidate will bring in-depth experience in pharma warehouse operations, with a proven track record of managing large-scale warehouse functions efficiently.

About the Role: Grade Level (for internal use): 10 About the Role: EMEA Benefits Specialist The Team: The Global Benefits Team is a team of specialists that focuses on the Wellbeing and Benefits for our colleagues across the globe supporting 40+ countries. The Impact We invest in our success as a company by investing in our people. At S&P Global, we are committed to comprehensive, competitive benefits for our people. We provide benefits to support the health and financial needs of our people while helping make their working life experience more rewarding. This is a critical role that touches each of our colleagues and is critical to our People First Philosophy. This role supports the wellbeing needs of our people while helping make their working life experience more rewarding. Whats in it for you To grow with a global company and learn more about key global benefits initiatives around the world. S&P Global puts our people first, and you will have the opportunity to participate in making positive change through global programs such as Wellbeing Reimbursement, Global Education, Global Parental Leave, Flexible Time Off program, Global EAP, Insured and Retirement benefits in the EMEA region. Responsibilities Manage benefits administration, renewals and day-to-day operations Support benefits programs involving the research and implementation of plans and programs as well as managing competitive benefits offered in the APAC region Subject matter expert for all benefits queries and escalations while also providing guidance and support to various business units Work closely with the external vendors, local leadership of the respective countries, HR partners, and other functions to offer best in class benefits and service to our employees Support APAC benefits projects and implementation related projects from beginning to end including benefits communication creation Develop and maintain policies and other documentation to educate all employees about the companys benefits programs. You'll be asked to work from office 2 days a week. What Were Looking For: Basic Required Qualifications: 4 years' minimum benefits experience Fluent English Exposure to managing benefits plans including benefits related regulatory and tax requirements Benefits project management skills. Capable of managing multiple tasks in an organized manner whilst interacting with various external and internal stakeholders Ability to engage and communicate effectively with employees and stakeholders while understanding their needs Microsoft Excel and PowerPoint experience. A self-starter that is motivated to achieve results whilst also being a team player Accurate, with great attention to detail A positive, flexible and proactive approach Additional Preferred Qualifications: German or French language will be beneficial Bachelor's degree desirable Workday knowledge is a plus If you meet the above qualifications and are passionate about designing and managing employee benefit programs, we would love to hear from you. Return to Work Have you taken time out for caring responsibilities and are now looking to return to workAs part of our Return to Work initiative, Restart, we are encouraging enthusiastic and talented returners to apply, and will actively support your return to the workplace. Whats In It For You Our Purpose: Progress is not a self-starter. It requires a catalyst to be set in motion. Information, imagination, people, technologythe right combination can unlock possibility and change the world.Our world is in transition and getting more complex by the day. We push past expected observations and seek out new levels of understanding so that we can help companies, governments and individuals make an impact on tomorrow. At S&P Global we transform data into Essential Intelligence, pinpointing risks and opening possibilities. We Accelerate Progress. Our People: Our Values: Integrity, Discovery, Partnership At S&P Global, we focus on Powering Global Markets. Throughout our history, the world's leading organizations have relied on us for the Essential Intelligence they need to make confident decisions about the road ahead. We start with a foundation of integrity in all we do, bring a spirit of discovery to our work, and collaborate in close partnership with each other and our customers to achieve shared goals. Benefits: We take care of you, so you cantake care of business. We care about our people. Thats why we provide everything youand your careerneed to thrive at S&P Global. Health & WellnessHealth care coverage designed for the mind and body. Continuous LearningAccess a wealth of resources to grow your career and learn valuable new skills. Invest in Your FutureSecure your financial future through competitive pay, retirement planning, a continuing education program with a company-matched student loan contribution, and financial wellness programs. Family Friendly PerksIts not just about you. S&P Global has perks for your partners and little ones, too, with some best-in class benefits for families. Beyond the BasicsFrom retail discounts to referral incentive awardssmall perks can make a big difference. For more information on benefits by country visithttps://spgbenefits.com/benefit-summaries Global Hiring and Opportunity at S&P Global: At S&P Global, we are committed to fostering a connected andengaged workplace where all individuals have access to opportunities based on their skills, experience, and contributions. Our hiring practices emphasize fairness, transparency, and merit, ensuring that we attract and retain top talent. By valuing different perspectives and promoting a culture of respect and collaboration, we drive innovation and power global markets. Recruitment Fraud Alert If you receive an email from a spglobalind.com domain or any other regionally based domains, it is a scam and should be reported to reportfraud@spglobal.com. S&P Global never requires any candidate to pay money for job applications, interviews, offer letters, pre-employment training or for equipment/delivery of equipment. Stay informed and protect yourself from recruitment fraud by reviewing our guidelines, fraudulent domains, and how to report suspicious activity here. ---- Equal Opportunity Employer S&P Global is an equal opportunity employer and all qualified candidates will receive consideration for employment without regard to race/ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, military veteran status, unemployment status, or any other status protected by law. Only electronic job submissions will be considered for employment. If you need an accommodation during the application process due to a disability, please send an email to EEO.Compliance@spglobal.com and your request will be forwarded to the appropriate person. US Candidates Only The EEO is the Law Poster http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf describes discrimination protections under federal law. Pay Transparency Nondiscrimination Provision - https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf ---- HUMRES202.1 - Middle Professional Tier I (EEO Job Group)

We are hiring Research Officer/ Research Executive at our R&D (Preferably Male Candidate) Location: Navi Mumbai Job Responsibilities: Analytical Method Development and validation of Assay, Dissolution and Organic impurity by using HPLC. Chemical Analysis raw material / finished product. Qualifications, Calibration of all instruments and Equipments as and when required. Method transfer to plant. Monitoring and Maintaining of GLP, GDP & compliance to audit points. Support and coordination for activity related to Project and Lab responsibility. Coordination with service engineers for instrument and equipment maintenance and trouble shooting. Support for training to juniors & new joiner. Keeping track of Chemicals inventory and coordination with Store keeper and purchase department for receipt of the same. Interaction with departments - Project management, Regulatory affairs, R&D- QA, Goa plant and FD. Any other analytical related activity as per company requirement. Qualification: Must be M Pharma/B Pharma/ M.Sc Minimum 6-9 yrs of Experience. Interested Candidate can directly walk in for Interview on the below address: Marksans Pharma Limited D-185/186, TTC Industrial Area, T.B Road, MIDC Shirvane, Navi Mumbai-400706. Landmark: Opp to Courtyard Hotel Lane Date: 26th July 2025 Time: 10 am to 4:30 pm Contact Person: Mr. Vijendra Auti 022-62241200 / 022- 40012000

Required an exp HR & IR professional with strong exposure in compliance, payroll & industrial relations. Must be well-versed in local language & labor law Statutory Compliance & Labor Law Adherence Payroll Time Office MGT Employee Relations & Welfare Required Candidate profile 12–18yrs of HR & IR exp in manufacturing setup Excellent knowledge of Indian labor laws and statutory compliance Proficiency in local languages (Telugu for Hyderabad, Konkani/Hindi for Goa) preferred

Objectives Of The Position Responsible for Regulatory strategy of South Asia, ASEAN, ANZ (close collaboration with strategic Regulatory management team) Responsible for all compliance activities in South Asia, ASEAN, ANZ Responsible for all registration activities in South Asia, ASEAN, ANZ Consolidate and communicate prioritization of product registrations and regulatory submissions Provide customer support beyond BASF for end users, supporting customers in preparation of drug product submissions and responses to deficiency questions from Health authorities Consolidate and communicate development in the South Asia, ASEAN, ANZ regulatory environment Regulatory representative for BASF Pharma in South Asia, ASEAN, ANZ Main Areas If Responsibility And Key Activities Regulatory Prepare and compile the checklist and documents for Active Ingredients, New application and renewal applications; Coordinate with global and regional regulatory on strategizing the approach for new and renewal application submission, authority deficiency questions and post approval variations Coordinate with global and regional regulatory for regulatory/quality documents support for customer requests Understand the gaps on the analytical questions from customers and provide interim or immediate support Establish an overview on upcoming and updated regulatory guidelines and identify the top focus topics for South Asia, ASEAN, ANZ Actively participate in the Regulatory process including monthly/ quarterly country calls, regional reporting and Global RA meetings Customer support Provide complete and timely support to internal and external customers on regulatory matters Industry representation Represent BASF Pharma at South Asia Pharma/Excipients associations (e-g IPEC India) Others Engage with South Asia sales head and sales colleagues to understand the business needs and potential Job Requirements Minimum Bachelor Degree in Science/ Pharmacy Minimum 5 years of regulatory and quality experience in pharmaceutical industry Understand India regulatory and US FDA guidelines Prior experiences in Regulatory Affairs/ Quality Control laboratory Team player with strong communication skills Can speak English and Hindi (preferred)