1269 Regulatory Affairs Jobs - Page 12

As a Senior Chemist in the Pharma Manufacturing Industry based in Vatva, Ahmedabad, you will be responsible for the synthesis of APIs and intermediates. Your role will involve conducting feasibility studies, selecting synthesis routes, and implementing multi-step synthesis processes to improve yield and reduce costs. You will utilize your expertise in conducting literature searches using platforms such as SciFinder, Chemical Abstracts, and Free Patent Online, as well as referring to various journals. Additionally, you will be involved in extraction, purification, and distillation processes, along with conducting lab validations. Strong documentation skills are essential for this role, including the preparation of technical reports, process safety reports, and cost sheets. You will also play a key role in technology transfer activities from the laboratory to kilo lab and plant scale. Collaboration with departments such as IPR, Regulatory Affairs, and QA will be crucial in ensuring compliance and quality standards are met. Proficiency in tools like Chemdraw and Chemsketch will be beneficial for this role. Please note that this position is open to male candidates with a background in the Pharma Manufacturing Industry. If you have a Master's degree in Organic Chemistry and possess 5 to 8 years of relevant experience in API and intermediates manufacturing within the Pharma industry, we encourage you to apply for this full-time, permanent position. For further details or to express your interest, please contact Himani (HR) at 9377165778. Thank you.,

You will be joining USV Private Limited, a leading pharmaceutical company in India known for its expertise in the diabetes and cardio sectors, with a global presence in over 65 countries. Your role will be in the Biologics function, specifically as an Assistant Manager or Manager in Regulatory Affairs (Clinical Trials) focusing on the EU and US markets. You will be based in Govandi (East), Mumbai, with a work schedule that includes working on the 1st, 3rd, and 5th Saturdays, while having the 2nd and 4th Saturdays off. To be considered for this position, you should have a qualification of M.Pharm/B.Pharm along with 5-15 years of relevant work experience in Regulatory Affairs-Clinical Trials for the EU and US markets. As part of your responsibilities, you will be involved in developing the Biosimilar Clinical Development Strategy, overseeing clinical trials and injectables for the EU and US markets. You will also be responsible for designing and finalizing clinical protocols, as well as managing Clinical Trial Applications and reviewing Clinical Study reports. Additionally, your role will include authoring and reviewing Biologics/Biosimilar Dossiers, with hands-on experience in eCTD submissions for the EU and US markets. You will handle Ministry of Health (MOH) queries, contribute to Product Life Cycle Management, and provide Regulatory Affairs support for plant-related Quality Management System (QMS) activities.,

Job Summary As a Sr. Consultant specializing in Devices you will play a pivotal role in driving innovative solutions and strategies for our clients. With a hybrid work model and day shifts you will collaborate with cross-functional teams to enhance device-related processes and outcomes. Your expertise will contribute to the companys mission of delivering cutting-edge technology solutions that positively impact society. Responsibilities Lead the development and implementation of device strategies to optimize client outcomes and enhance operational efficiency. Oversee the analysis of device-related data to identify trends and opportunities for improvement. Provide expert guidance on device selection integration and lifecycle management to ensure alignment with client objectives. Collaborate with cross-functional teams to design and execute device-related projects that meet client needs and expectations. Develop and maintain strong relationships with clients to understand their device requirements and provide tailored solutions. Ensure compliance with industry standards and regulations in all device-related activities. Drive continuous improvement initiatives to enhance device performance and reliability. Conduct training sessions and workshops to educate clients and internal teams on device best practices. Monitor and report on the progress of device projects ensuring timely delivery and quality outcomes. Support the development of proposals and presentations for potential device-related projects. Evaluate emerging device technologies and trends to identify opportunities for innovation. Facilitate knowledge sharing and collaboration among team members to foster a culture of learning and growth. Utilize your domain expertise to contribute to the companys strategic goals and enhance its reputation in the device sector. Qualifications Possess a minimum of 8 years of experience in the devices domain demonstrating a strong track record of success. Exhibit excellent analytical skills to interpret complex device data and derive actionable insights. Demonstrate proficiency in device lifecycle management and integration strategies. Have a solid understanding of industry standards and regulatory requirements related to devices. Show exceptional communication skills to effectively convey technical information to diverse audiences. Display strong problem-solving abilities to address device-related challenges and implement effective solutions.

JOB PROFILE OF SR. TECHNICAL OFFICER-QUALITY ASSURANCE MENDINE PHARMACEUTICALS PVT LTD Job Title / Designation- SENIOR TECHNICAL OFFICER - QA Qualifications- M.PHARM Experience- 5 to 6 years experience in QUALITY ASSURANCE Job Objective- The ideal candidate will be responsible for implementing and maintaining quality systems, ensuring compliance with cGMP guidelines, conducting internal audits, reviewing batch records, and supporting regulatory inspections. This role demands strong documentation skills, a sound understanding of pharmaceutical quality standards, and the ability to work collaboratively across departments to uphold product integrity and safety throughout the manufacturing process. Job Responsibilities 1) Quality Risk Management 2) Batch Manufacturing Record preparation 3) Process Validation 4) Packaging Material Specification Preparation 5) APQR 6) Cleaning Validation 7) Regulatory Affairs activity 8) Dossier preparation 9) Application of ONDLS system 10) Form 29 & Form 30 preparation 11) Endorse documents preparation 12) New drug application 13) COPP application in ONDLS.

Sr.Manager Compliance L6, Target Plus (T+) Target is an iconic brand, a Fortune 50 company, and one of Americas leading retailers.Alongside Targets distinctive retail presence, our digital footprint is rapidly evolving to deliver a world-class online shopping experience. If you thrive in a fast-paced environment and are passionate about retail innovation, youll find success in Target Plus , Targets curated third-party marketplace. Here, youll collaborate to shape digital strategies that support scalable growth and drive operational excellence for our sellers and guests.You will play a critical role in ensuring adherence to all relevant regulatory requirements and product safety standards. This position involves close partnership with stakeholders across Legal, Compliance, Product Safety & Quality Assurance, Digital Operations, Data Analytics, Guest Services, and Product teams. Your work will focus on building proactive compliance frameworks, synthesizing complex regulations, and enabling business readiness through clear processes and strong cross-functional alignment. Key Responsibilities: Proactively monitor federal, state, and industry-specific regulations, bans, standards, and legislative developments impacting the marketplace. Analyze regulatory risk and assess its impact on Target Plus policies, processes, and product assortment. Develop and implement scalable compliance strategies to align with evolving rules and regulatory expectations. Partner cross-functionally to identify and close operational gaps in compliance preparedness. Lead internal education efforts to build awareness and drive readiness for regulatory and product safety changes. Serve as the key liaison for compliance-related issue management, ensuring timely resolution and alignment across stakeholders. Influence business and product roadmaps with compliance perspectives to minimize risk and ensure guest trust. Support cross-functional alignment by clearly communicating compliance risks and mitigation strategies. Qualifications: Four-year degree or equivalent experience 8+ years of experience in compliance, marketplace operations, regulatory affairs, or a related field Prior experience in e-commerce or marketplace compliance is highly preferred Strong analytical and problem-solving skills with the ability to turn insights into action Excellent communication skills and the ability to engage mid-to-senior-level stakeholders Proven ability to lead initiatives in a cross-functional and matrixed environment Experience partnering with Product and Legal teams is a strong advantage

If your location allows for pay/benefit transparency, please click the link below to request further information on this position. Pay Transparency Request Form This position is 100% remote. PURPOSE AND SCOPE: Responsible for leading the strategic direction and execution of regulatory strategies for our global pharmaceutical portfolio. This position plays a critical role in influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for FME s product portfolio. The Global Strategy Leader will work closely with internal and external stakeholders to align regulatory strategies with business objectives and drive the timely delivery of high-quality pharmaceutical products. PRINCIPAL DUTIES AND RESPONSIBILITIES: Regulatory Strategy Leadership: Lead the development of global regulatory strategies for the company s pharmaceutical portfolio, including IND/CTAs, NDAs, NDSs, MAAs, etc..and other key regulatory submissions. Collaborate with senior leadership in medical/clinical development, commercial, and other functional areas to align regulatory strategy with overall product development and business objectives. Provide expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization. Global Regulatory Submissions: Oversee the planning, preparation, and execution of global regulatory submissions to ensure timely approval and market access across key regions (e.g., FDA, EMA, Health Canada, etc.). Including global chemistry, manufacturing, and controls writers and authorship Ensure the integration of regulatory considerations into all stages of product development, including preclinical, clinical/medical, CMC, and post-market phases. Monitor regulatory trends, updates, and guidance from global agencies, ensuring the company s strategies remain aligned with changing regulatory requirements. Cross-Functional Collaboration & Stakeholder Management: Serve as a regulatory contact for cross-functional teams, ensuring alignment on regulatory strategy and execution across global markets. Work closely with commercial, clinical/medical, and manufacturing teams to ensure timely and successful regulatory approval of products, addressing any regulatory challenges that arise. Lead interactions with regulatory agencies and stakeholders worldwide to advocate for regulatory positions, influence decisions, and expedite approvals. Regulatory Risk Management & Compliance: Identify and manage regulatory risks associated with the global development and commercialization of pharmaceutical products. Ensure compliance with local and global regulatory standards, including FDA, EMA, ICH, and other regulatory bodies, to maintain market access and product integrity. Develop and implement strategies to address potential regulatory roadblocks or challenges, ensuring the company remains on track to meet business goals. Team Leadership & Development: Lead, mentor, and develop a high-performing team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement. Build and maintain strong, productive relationships with global regulatory authorities and external stakeholders, such as consultants, regulatory agencies, and industry groups. Provide leadership in managing global regulatory submissions, ensuring efficient and high-quality execution. Market Access and Competitive Intelligence: Assess and anticipate the competitive landscape and market trends to inform the regulatory strategy and market access plans. Utilize market intelligence and regulatory data to optimize product lifecycle management, regulatory strategy, and portfolio prioritization. PHYSICAL DEMANDS AND WORKING CONDITIONS : The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 10 - 15% domestic and international travel required. EXPEREINCE AND REQUIRED SKILLS: Education: Bachelor s degree in Life Sciences, Pharmacy, Chemistry, or a related field (Advanced degree such as a Master s, PhD, or MBA is highly preferred). Regulatory Affairs Certification (e.g., RAC) is preferred. Experience: 12+ years of experience in regulatory affairs, focusing on regulatory strategy, submissions, and global market access in the pharmaceutical industry. Proven experience in leading global regulatory strategy for complex pharmaceutical products across multiple regions (FDA, EMA, HC, etc.). Strong expertise in navigating regulatory pathways for drug strategy, from preclinical through post-market. Demonstrated success in leading and mentoring a team of regulatory professionals in a fast-paced, global environment. Experience managing large-scale global regulatory submissions, including IND/CTAs, NDAs, NDSs, and MAAs, etc.. Skills & Competencies: Strategic thinker with a deep understanding of the global regulatory environment and pharmaceutical industry trends. Exceptional leadership and team-building skills, with the ability to manage and inspire cross-functional teams. Strong project management skills, with a proven track record of delivering regulatory submissions on time and within scope. Excellent communication, presentation, and negotiation skills, with the ability to influence senior leadership and regulatory agencies. Analytical mindset, capable of identifying risks and proposing solutions to address regulatory challenges. Proven ability to navigate complex regulatory landscapes and deliver strategic solutions that drive product success. Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance. EO/AA Employer: Minorities / Females / Veterans / Disability / Sexual Orientation/Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws. EOE, disability/veterans

Rama Super Speciality Hospital is looking for ENT Surgeon to join our dynamic team and embark on a rewarding career journeyExamining patients to diagnose and evaluate their medical conditions, including the use of diagnostic equipment and tests such as X-rays and MRI scans.Developing and implementing treatment plans, including the use of surgical procedures and other medical therapies.Performing surgical procedures to treat conditions such as ear infections, hearing loss, sinusitis, voice and speech disorders, sleep apnea, and head and neck tumors.Communicating with patients and their families, discussing diagnoses and treatments, and answering questions and concerns.Collaborating with other medical specialists, such as neurologists, audiologist, and speech therapists, to provide comprehensive patient care.Maintaining accurate and complete patient records, including medical history, exam results, diagnostic images, and treatment plans.Participating in continuing education programs and conferences to maintain and improve surgical skills and knowledge.Ensuring that all medical equipment is properly maintained and in compliance with safety regulations.

Prepare and submit regulatory dossiers for product registrations, import licenses, and amendments to the CDSCO. Maintain up-to-date knowledge of Indian medical device regulations (Medical Device Rules, 2017 and amendments). Liaise with CDSCO, state licensing authorities, and third-party regulatory consultants. Support Quality Assurance in audits, product recalls, and field safety corrective actions. Ensure compliance with India-specific labeling, documentation, and advertising regulations. Monitor and assess changes in regulatory guidelines and communicate impact to cross-functional teams. Maintain regulatory files and tracking systems for timely renewals and updates. Collaborate with global regulatory teams to ensure consistent strategies and compliance. Requirement: Master s degree in Pharmacy or a related field 5 8 years of hands-on experience in regulatory affairs for medical devices and experience with Class C & D devices preferred Strong knowledge of CDSCO regulations and submission pathways Excellent communication and project management skills Familiarity with ISO 13485, EU MDR, and US FDA regulations is a plus

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Environment Health and Safety Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : BE or BTech or MTech Summary :As a Tech Delivery SME Environment Health and Safety, you will play a key role in delivering innovative EHS technology solutions for clients. You will apply deep domain expertise to drive transformational outcomes and embed best practices into delivery engagements. This role requires direct interaction with clients, acting as a trusted advisor to understand business needs, define requirements, and implement effective solutions. Roles & Responsibilities:1) Lead the design, development, and delivery of EHS technology solutions aligned with client objectives.2) Collaborate with cross-functional teams to gather requirements and ensure effective solution design and implementation.3) Serve as a subject matter expert on global EHS regulations, trends, and best practices.4) Translate complex technical and regulatory concepts into actionable insights for clients.5) Foster innovation by introducing emerging EHS practices and supporting Accentures strategic positioning in the market.6) Build and maintain strong relationships with key stakeholders to ensure consistent delivery excellence. Professional & Technical Skills: 1) Deep technical knowledge of EHS regulations, compliance standards, and industry best practices.2) Strong business acumen with the ability to align technology with strategic business goals.3) Excellent verbal and written communication skills; ability to engage with senior stakeholders as a trusted advisor.4) Hands-on experience with EHS software solutions (e.g., Enablon, SAP EHS, Intelex, Sphera, etc.).5) Project management experience in a client-facing or consulting environment.6) Proficiency in data analysis and reporting to support compliance and operational insights.7) Solid understanding of risk management and regulatory frameworks in EHS. Additional Information:Minimum 12 years of relevant experience in the Environment Health and Safety domain, with demonstrated leadership in solution delivery and client engagement.This position is based on Bengaluru locationA 15 years of full time education is required. Qualification BE or BTech or MTech

Seeking for experienced & strategic Regulatory Affair leader. will oversee all regulatory submission activities, maintain compliance with evolving global health authority requirements & provide expert regulatory guidance for pharmaceutical products

Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for new registrations, renewals, and variations. • Ensure dossiers and query responses are complete and compliant. • Coordinate with plants for registration samples and related documentation. Stakeholder Collaboration: • Work with internal teams and external partners to gather and finalize technical documents. Regulatory Operations Oversight: • Compile and submit responses to MOH/partner queries on time. • Track regulatory submissions as per calendar. • Oversee renewals of FDA licenses, WHO GMP, COPPs, etc. Training & Regulatory Intelligence: • Conduct training on updated guidelines. • Share critical regulatory updates with teams. Documentation & Reporting: • Review technical and administrative dossier sections. • Maintain monthly regulatory status reports. • Coordinate site registrations and pre-audit activities. Leadership & Team Development: • Guide the RA team for efficiency and compliance. • Promote process improvements and regulatory best practices. • Handle additional tasks under the RA function. neetij@selectsourceintl.com

Veeva Vault-RegulatoryOne Administrator: The Veeva Vault-RegulatoryOne Administrator oversees the maintenance, development, implementation and roll-out of Veeva RegulatoryOne for UPL Regulatory Affairs. RegulatoryOne is the application used by Regulatory Affairs team to manage regulatory data and documents to run regulatory activities primarily. UPL adopted RegulatoryOne globally in 2022 and is continuously extending the scope and features. Our objective is to leverage RegulatoryOne for the benefit of other functions such as Marketing or Supply Chain by integrating with their IT applications (ERP, CRM, etc.). The focus for the next 12 months will be on dossier management (binders), document request workflow, and Registration Dossier Management (RDM). ROLES AND RESPONSIBILITIES : Understand the Customer business requirement and processes and translate them into a successful Application design. Collect business requirements from internal stakeholders to create and enhance innovative digital solutions or features. Administer the regulatory content management solution, i.e.: Organize, monitor, and maintain documents, data, user groups, templates, and reports as business administrator, Manage User access and security settings, document types and objects, Monitor, maintain, and troubleshoot lifecycles, workflows, atomic security and Dynamic Access Control Configure the Application or manage the contractor, if any. Manage the Product Backlog. Coordinate with IT functions regarding infra, security, system interconnexion, etc. Work on integration with other applications. Guide Data Analytics team to create dashboards. Update documentation detailing the configuration & customization Manage data and document migration to the Application when necessary. Set up and roll out training sessions to digital applications to end-users (incl. refresh sessions) to ensure a high level of adoption. CORE SKILLS Veeva RegulatoryOne / Vault configuration & customization Document management (classification, fields, field dependencies) Object management Lifecycles & Workflows Security management (incl. Matching rules, Custom Sharing Rules, etc.) Reporting & Dashboards RDM feature (Requirements, Split rules, Relational Tokens, Local Impact Assessment) Optionally SDK Running APIs (Postman) IT Application integration Business Process Management. Document and Data management. Optionally Agile Project Management methodology. Excellent oral communication in English. SOFT SKILLS High-Quality Work driven. Stakeholder/customer oriented. Autonomous (manager on remote) Rigorous. Team player IT TOOLS Veeva Vault, ideally RegulatoryOne Microsoft 365 Data visualization applications (e.g. Power BI, Qlik Sense)

Role & responsibilities * Data Entry and Updation in Regulatory Information Management System. * Dossier preparation (New/ Renewal/ Variations) for different countries. * Other RA Related Activities. Perks and benefits * 5 days working Environment * Additional Benefits.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

Senior Manager Job Role Process designing for Credit Cards covering key aspects of Process Workflows (Digital Physical), Compliance, Risk, Legal, Ops, Customer Experience, etc. Creating and documenting SOPs/Process notes of various Credit Card processes with clear defined roles and responsibilities to promote efficient implementation. Ability to think through end to end process at various touchpoints such as online channels, partners, Branches, Call center etc. Review processes in light of Fraud and Risk raised by RCU and ORM. Identification of Risks and Regulatory breach on cards processes and provide solution to mitigate risks and control reports to minimize process lapses. Monitor and govern if the defined processes are being executed from time to time, including regulatory changes In-depth understanding of KYC and Other Regulatory Guidelines. Providing tailor made solution to Product Operations for specific business requirement. Ideate & suggest Product and Operations with end to end execution of a Process Digital Journey"s new initiatives features etc. Ensuring the Digital Journey controls and logics is in line with defined Process, Regulation and Risk perspective Responsible for the documentation of Business Processes, workflows. Publish MIS and Reports Job Requirement Graduate/Post-Graduate with at least 5 to 6 years of experience in Business Processes In-depth knowledge of Credit Cards business Knowledge of Regulatory requirements and market competition/intelligence will be an added advantage. Excellent communication skills Verbal & Written Good Logical reasoning and data analysis skill Should be able to think proactively for process changes from Business Process Re-engineering perspective Assertive attitude Self-Driven and ability to follow-up promptly Good analytical skills & eye for details

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best practices to stakeholders. Job Requirements Strong understanding of risk management principles and practices. Excellent analytical and problem-solving skills with attention to detail. Ability to work effectively in a fast-paced environment with multiple priorities. Strong communication and interpersonal skills, with the ability to build relationships with stakeholders. Experience working with financial data and systems, including risk management software. Strong knowledge of regulatory requirements and industry standards related to risk management.

Location: Wegmans Business Park ( Greater Noida) Exp 2 to 5 years Excellent Writing and Spoken English required Monday to Saturday - Critical Minerals Domain About the Role We are seeking an experienced individual to join our team as the Member of Public Affairs. In this key role, you will be responsible for shaping and executing our policy & government relations strategy, enabling us to navigate the complex regulatory landscape, secure government incentives, and foster positive relationships with key stakeholders. Responsibilities Advocacy : Lead efforts to advocate for client with government bodies and industry stakeholders. Foster relationships with key officials, monitor policy changes, and provide strategic guidance. Policy Monitoring and Analysis : Track and report on policy developments, regulatory changes, and emerging risks that may impact the company's operations or strategic direction at local, national & global level. Educate the internal stakeholders on the impact of policies and provide guidance to relevant business lines. Policy Communication and Thought Leadership : Represent the company in industry forums, conferences, and working groups to influence policy discussions and promote our expertise in energy transition materials circularity. Grant Acquisition and Government Incentives : Identify and pursue grants and incentives to support company projects. Prepare grant applications and ensure compliance with requirements. Tracking government policies in sectors of interest Preparing briefs, reports, and presentations for the senior leadership Aiding business and technical teams in understanding policies Qualifications 1 to 5 years of experience in policy, public affairs, or with the government in any capacity Good Understanding of Indias bureaucratic structure Strong network of contacts within government, think tanks, and industry associations Understanding of regulations and policies in industries that client operates in environment, chemicals, EVs, mobility Exceptional communication skills, including the ability to make presentations conveying complex information in a clear and compelling manner. Good academic background with some grounding in law, economics, finance or accountancy.

As a highly organized Cybersecurity Officer at AmeriPharma, you will play a crucial role in managing system-wide healthcare compliance, information security, and privacy regulations. Reporting to the Director of Regulatory Affairs, you will be responsible for ensuring regulatory excellence, information security, and adherence to federal and state laws. Your primary focus will be on fostering a culture of accountability, trust, and risk management across all IT infrastructures. Your duties will involve developing and managing a comprehensive cybersecurity program in compliance with regulations such as HITECH, providing cybersecurity support during software and network development, conducting security and risk assessments, and managing annual risk assessments, vulnerability management, and penetration testing. You will also be responsible for implementing security measures, overseeing compliance with patient data protection regulations, and managing cyber threats, incident response, and forensic investigations. To be successful in this role, you must have expertise in HIPAA, HITECH, HITRUST, and cybersecurity frameworks, along with extensive experience in risk management, information security, and regulatory compliance auditing. Strong technical knowledge in network security, cloud security, and identity access management is essential, as well as exceptional communication skills and the ability to make strategic, data-driven decisions in high-pressure environments. You will collaborate with IT teams to improve security controls across cloud, network, and endpoints, lead cybersecurity awareness training programs for employees, align cybersecurity initiatives with business objectives, and innovate in cybersecurity frameworks, AI-driven threat detection, and cloud security. Additionally, you will engage with industry leaders and regulatory bodies on emerging cybersecurity threats and develop and test software applications using Agile methodologies. The ideal candidate will have a Bachelor's degree in Computer Science, Information Technology, or a related field, along with certifications such as CompTIA A+, Network+, CISSP, CCNA, MSCE, or MCSD. A minimum of 4 years of experience in Engineering, Software Engineering, or related fields is required, as well as proficiency in cybersecurity tools and platforms. If you are passionate about cybersecurity, have a strong background in regulatory compliance and risk management, and are looking for a challenging and rewarding opportunity to make a difference in healthcare IT security, we invite you to join our dynamic team at AmeriPharma.,

Jubilant Pharma Limited is a global integrated pharmaceutical company that offers a wide range of products and services to customers across various geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Specialty Pharmaceuticals segment includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products. Generics & APIs segment comprises Solid Dosage Formulations & Active Pharmaceutical Ingredients. Jubilant Generics (JGL) is a wholly-owned subsidiary of Jubilant Pharma with Research & Development units in Noida and Mysore, India. It operates two manufacturing facilities in Mysore, Karnataka, and Roorkee, Uttarakhand, focusing on APIs and Dosage manufacturing. The Mysore manufacturing site, spread over 69 acres, is a USFDA approved facility catering to global sales with a portfolio concentrating on Lifestyle-driven Therapeutic Areas like CVS, CNS. The Roorkee facility is state-of-the-art and approved by multiple regulatory bodies including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA, following a B2B model for EU, Canada, and emerging markets. Both manufacturing units are backward-integrated and supported by approximately 500 research and development professionals in Noida and Mysore. R&D efforts include developing new products in API, Solid Dosage Formulations, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. JGL's Regulatory Affairs & IPR professionals maintain a unique portfolio of patents and product filings in regulatory and non-regulatory markets. Jubilant Pharma's revenue has been consistently growing, reaching INR 53,240 Million during the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. For more information about the organization, please visit www.jubilantpharma.com.,

The position of Manager is open in the Global Regulatory Affairs Specialty Pharma department. As a Regulatory CMC Product team member, you will provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned branded products being developed for the US and other advanced markets like EU & Canada. Your responsibilities will include ensuring lifecycle management by submitting annual reports and supplements in a timely manner to ensure product continuity. You will be accountable for the delivery of all regulatory milestones for higher complexity products, including assessing the probability of regulatory success and implementing risk mitigation measures. In this role, you will lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Additionally, you will provide regulatory leadership in product in-license/due diligence review, product divestment, and product withdrawal. Managing the execution of CMC documentation, supporting new technology development, and ensuring compliance with a focus on regulatory affairs will also be part of your responsibilities. You may also be required to manage or mentor junior team members. As a candidate for this position, you are expected to have hands-on expertise in the preparation & review of dossiers, response to queries, and communication with agencies for developed markets like the US/EU. Your experience in critically reviewing detailed scientific information, demonstrating superior oral and written communication skills, and understanding related fields such as manufacturing, analytical, and quality assurance will be crucial. Your ability to generate innovative solutions to complex regulatory problems, work effectively with key stakeholders, and demonstrate flexibility in responding to changing priorities will be highly valued. To qualify for this role, you should have a minimum of 5-10+ years of experience in regulatory affairs, with proficiency in English and additional language skills considered a plus. Strong inter-personnel skills, the ability to direct multi-departmental functions, and effective leadership, communication, interpersonal, and negotiating skills are essential for this position. A Master's degree in Pharmacy (M. Pharm) in pharmaceutical sciences is required for this role.,

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. The business is organized into two segments: Specialty Pharmaceuticals and Generics & APIs. Jubilant Generics (JGL), a wholly-owned subsidiary of Jubilant Pharma, operates Research & Development units in Noida and Mysore, India. The company has two manufacturing facilities - one in Mysore, Karnataka, and another in Roorkee, Uttarakhand - engaged in the production of APIs and Dosage manufacturing. The Mysore manufacturing location, spread over 69 acres, is a USFDA approved site specializing in manufacturing APIs for Lifestyle driven Therapeutic Areas such as CVS and CNS. It is a market leader in four APIs and among the top three players for three other APIs in its portfolio. On the other hand, the Roorkee facility is a state-of-the-art site approved by multiple regulatory bodies including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA. This facility focuses on a B2B model for EU, Canada, and emerging markets. Both manufacturing units are supported by approximately 500 research and development professionals based at Noida and Mysore. The R&D team works on developing new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. Additionally, all BA/BE studies are conducted in-house at an 80-bed facility with approvals from various regulatory authorities. JGL's Regulatory Affairs & IPR professionals ensure a unique portfolio of patents and product filings in regulatory and non-regulatory markets. Jubilant Pharma's revenue has shown a constant increase, reaching INR 53,240 Million in the Financial Year 2018-19 compared to INR 39,950 Million in the Financial Year 2017-18. For more information about the organization, please visit www.jubilantpharma.com.,

You will be working as a full-time Regulatory Compliance Manager based in Delhi, India. Your primary responsibility will be to ensure the company's compliance with SEZ, Custom (MOOWR, AEO, SVB), DGFT, and FSSAI regulations. This involves obtaining permissions from Custom, implementing compliance mechanisms for MOOWR and AEO with Custom authorities, and liaising with Custom and SEZ authorities to secure necessary approvals for clients of Laureate in a timely manner. To excel in this role, you should possess a strong understanding of regulatory compliance and requirements, particularly in Custom and SEZ domains. Your tasks will include obtaining permissions from DGFT authorities for Advance Authorization, SEIS, etc. Strong analytical skills and experience in Custom-related regulations and permissions are essential. A background in Regulatory Affairs and compliance, combined with excellent organizational and communication skills, will be beneficial. You must be able to work both independently and collaboratively, demonstrating a proactive approach to ensuring compliance. Any familiarity with regulatory standards in the environmental sector would be advantageous. A Bachelor's degree is required for this position. The salary offered will be as per industry standards.,

The position requires you to deliver excellent business results through your team's efforts. Your responsibilities include utilizing writing skills to create adverse event and product complaint narratives during intake and developing custom responses for medical inquiries. You will handle requests through various channels such as phone, email, CRM, and chat. It is crucial to identify adverse events and product complaints during customer interactions, accurately generate reports, and adhere to regulatory procedures. You will coordinate processes to address product quality-related complaints by collaborating with departments like Quality Assurance and Regulatory Affairs. Maintaining knowledge of product, therapeutic area, and client-specific requirements is essential. Emphasizing good documentation practices, high quality standards, and exceptional customer service is key. Additionally, showcasing a commitment to diversity, equity, and inclusion through continuous development and inclusive behaviors is expected. Minimum qualifications include a Pharm.D, Master of Science (Msc), B.Pharm, M.Pharm, or any other Life Sciences degree. Proficiency in documentation, verbal and written communication, and a strong clinical background is required. Fluency in English for speaking, reading, and writing is necessary. Preferred qualifications mirror the minimum requirements of education, experience, and skills outlined above.,

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.

To study the Transactional compliance Plan for every project and document the list of applicable Regulations and Standards Preparation of Compliance documents for specific projects with list of impacted items from the TRS Matrix Work with the suppliers to ensure that the parts / assemblies manufactured by them meet the compliance requirement of the project Collect and compile the documents / certificates for the project and upload the central repository Work with Design team on regular basis and initiate the improvement actions Adopt the best practices from other business and incorporate Schedule the meetings with other teams to ensure compliance is met