18 Regulatory Strategy Jobs

As a Corporate Legal Specialist with 12 years of professional legal experience, you will play a crucial role in supporting our in-house legal operations at Rx100 Ventures, a sector-specific deep tech venture platform headquartered in Bangalore, India. Your responsibilities will include contributing to corporate advisory, regulatory compliance, documentation vetting, and legal risk assessments. This position offers a rich opportunity to gain hands-on exposure to cross-functional corporate legal activities in a fast-paced, innovation-driven environment. You will be responsible for supporting the review and negotiation of commercial agreements, non-disclosure arrangements, term sheets, and investment-related legal documentation. Additionally, you will perform legal and regulatory research to assist internal stakeholders with compliance-related queries and strategic legal positioning. Your role will also involve drafting and structuring business agreements, providing internal guidance on governance practices, legal risk mitigation, and operational legal frameworks, as well as coordinating with external law firms or advisors on specialized legal matters. To excel in this role, you should hold an LL.B from a recognized university, with an LL.M being preferred. You must have 12 years of relevant legal experience, ideally in corporate/commercial law within a firm or corporate legal team. A strong understanding of business law, compliance frameworks, and corporate legal processes is essential, along with skills in communication, legal drafting, and contract negotiation. It is crucial to be self-driven, able to manage tasks independently, and collaborate effectively within diverse teams. Additionally, you should be licensed to practice law in India under the appropriate jurisdiction. Key Skills required for this position include expertise in Business & Corporate Law, Legal Risk Advisory, Commercial Contract Review, Legal Compliance and Reporting, M&A and Due Diligence Support, IP & Confidentiality Agreements, Legal Interpretation & Drafting, Internal Legal Consulting, Regulatory Strategy, and Corporate Legal Transactions.,

As a Regulatory Affairs Specialist, you will play a crucial role in supporting the product lifecycle through obsolescence. Your responsibilities will include assessing changes made to the device post-launch to determine the regulatory impact of these changes on current clearance. You will ensure regulatory compliance by conducting thorough assessments and submitting the necessary documentation for product clearances and approvals from regulatory bodies such as the FDA and Notified Bodies. In this role, you will support new product development for both domestic and international release by contributing to the development and updating of regulatory strategy based on regulatory changes. You will be seen as a valuable resource within the regulatory team, working with minimum supervision but keeping senior staff informed of your progress. Your tasks will involve developing and applying a basic understanding of regulatory frameworks, requirements, legislation, processes, and procedures. You will manage projects, write reports, coordinate regulatory activities, and execute regulatory assignments that are broad in nature. Additionally, you will assist in the development and review of standard operating procedures (SOPs) and contribute to regulatory strategy updates. You will provide regulatory input for new product development and product lifecycle planning, evaluate the regulatory impact of proposed changes to launched products, and investigate the regulatory history and background related to specific classes, diseases, therapeutics, or diagnostics for regulatory assessment. Your role will also involve determining and communicating submission and approval requirements to relevant stakeholders. To qualify for this position, you must have a Bachelor's or Master's degree in Regulatory Affairs, Engineering, or a related discipline. A minimum of 3-5 years of experience in a similar role within an R&D environment is preferred. Experience with post-market activities and change management will be advantageous, and holding an RAC Certification is also preferred. If you are looking to join a dynamic team where you can leverage your regulatory expertise to drive compliance and contribute to the successful launch of new products, this role may be the perfect fit for you. Apply now and be part of a team that is dedicated to ensuring regulatory excellence and innovation in the medical device industry.,

The position of Manager is currently open within the Global Regulatory Affairs Specialty Pharma department. The ideal candidate should hold a M. Pharm education and possess 5-10+ years of hands-on experience in regulatory affairs. The preferred job location is Gurgaon, with Baroda and Mumbai as alternative options. As a Regulatory CMC Product Lead, you will be responsible for providing CMC Regulatory leadership within Regulatory and on cross-functional teams for branded products being developed for markets such as the US, EU, and Canada. Your key responsibilities will include ensuring product lifecycle management through timely submission of annual reports and supplements, as well as delivering all regulatory milestones for higher complexity products. You will also be accountable for leading the development and review of the CMC Regulatory Strategy Document for projects of increasing complexity. In addition, you will be required to support new technology development within the company and demonstrate an unwavering focus on compliance in all activities. Your technical skills should include expertise in the preparation and review of dossiers, response to queries, and communication with agencies for markets like the US and EU. Furthermore, you should have proven experience in critically reviewing scientific information and possess superior oral and written communication skills in multicultural settings. The ideal candidate for this role will have demonstrated leadership skills, including the ability to generate innovative solutions to complex regulatory problems and effectively work with key stakeholders. You should also exhibit flexibility in responding to changing priorities and possess effective leadership, communication, interpersonal, and negotiating skills. Additionally, you should have good inter-personal skills with the ability to direct multi-departmental functions. This role requires a seasoned professional who is proficient in English, with additional language skills considered a plus. A minimum educational requirement of M-Pharm in pharmaceutical sciences is essential for this position. Lastly, you may be required to manage or mentor junior team members as part of your responsibilities.,

The Asset & Wealth Management Strategic Transformation Office is responsible for overseeing comprehensive large-scale transformations. The primary objectives of the office include enhancing scalability, driving revenue growth, improving client experience, and elevating controls to optimize the operating platform. This group consists of four critical functions: Product Management & Design, Change Management, Regulatory Management, and Monitoring & Testing. The AWM Regulatory Management team plays a key role in managing the regulatory strategy and roadmap for the AWM business globally. As the primary business partner for regulatory matters, the team is responsible for Regulatory Solutions and Regulatory Controls. Regulatory Solutions involve assessing the impact of regulations on business activities, participating in regulatory change governance forums, and supporting the design of appropriate solutions to deliver regulatory requirements. Regulatory Controls ensure a robust control framework is in place to evidence compliance. As a member of the AWM Regulatory Management team, you will: - Build a deep understanding of the Asset and Wealth Management business by analyzing the applicability and impact of regulatory policies and rules to various business areas - Collaborate with the team, key stakeholders, and regulatory experts to simplify complex regulatory challenges - Drive business engagement and lead strategic cross-divisional discussions on regulatory change matters - Utilize appropriate methodologies and governance tools to deliver analysis and agreed solution approaches in a timely manner - Establish strong senior stakeholder relationships necessary for complex analysis across multiple businesses Skills & experience we are looking for: - Bachelor's degree and 3 - 6 years of experience in management consulting or a related field in financial services with active involvement in new regulation assessments and implementations - Understanding of asset management products, the asset management operating model, and ecosystems - Proficiency in regulatory strategy, roadmap, analysis, and interpretation of new regulations for the business - Strong strategic mindset, analytical skills, problem-solving abilities, and critical thinking - Project management skills including defining business cases, articulating issues, solutions, and managing risks - Excellent communication and relationship-building skills with the ability to influence staff at all levels - Proven track record of owning, designing, and executing solutions for complex problems - Experience in Reg product and platform management is preferable - Ability to multitask and manage multiple projects simultaneously - Proficiency in MS Office, PowerPoint, and Excel, with the ability to learn new tools quickly Goldman Sachs is committed to fostering diversity and inclusion within the workplace and beyond. The firm offers numerous opportunities for professional and personal growth, including training and development programs, firm-wide networks, benefits, wellness offerings, personal finance resources, and mindfulness programs. Learn more about the culture, benefits, and people at GS.com/careers.,

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing change controls and performing gap analysis for new product filings. Additionally, you will be tasked with maintaining product life cycles and collaborating with cross-functional departments to evaluate, approve, and implement change proposals, deviations, and escalations. Furthermore, you will be responsible for preparing internal guidance documents to support regulatory activities within the organization. This position is based in Pune and focuses on the Canadian market, encompassing all types of dosage forms. A degree in B.Pharm/M.Pharm is required to qualify for this role.,

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

As the DM- Regulatory Affairs at Olympus Medical Systems India Private Limited, your primary responsibility will be to oversee Indian regulatory affairs activities related to Gastrointestinal (GI) & Olympus products. You will also be responsible for advising and consulting with stakeholders about compliance with CDSCO, BIS, WPC, and other applicable regulatory bodies. Your role will involve implementing best practices and contributing to both the strategic and operational functions of the regulatory affairs team. Your key responsibilities will include assessing regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. You will evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance. Anticipating regulatory obstacles and emerging issues, you will develop solutions and identify requirements and potential obstacles for market access distribution. Furthermore, you will assist in the development of regulatory strategy, update strategy based upon regulatory changes and evaluate proposed products for regulatory classification and jurisdiction. You will determine requirements for regulatory submission, approval pathways, and compliance activities while providing regulatory information and guidance for product development and planning. In addition, you will compare regulatory outcomes with initial product concepts, negotiate with regulatory authorities, and identify the need for new regulatory procedures. You will help train stakeholders on current and new regulatory requirements, provide regulatory input on global regulatory requirements to product development teams, and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data. You will also be responsible for assessing the acceptability of quality, preclinical, and clinical documents for submission filing, evaluating proposed changes for regulatory filing solutions, and monitoring the progress of the regulatory authority review process. Communication and interaction with regulatory authorities before and during the development and review of regulatory submissions will be crucial aspects of your role. To be considered for this position, you are required to have a qualification of M. Pharma/B Pharma along with a PG Diploma in Drug Regulatory Affairs. The preferred experience includes 12 to 15 years of working experience in a customer-oriented position in an international organization. Proficiency in MS Office, particularly Excel, and fluency in oral and written communication in English are essential. Key competencies for this role include business acumen, customer focus (internal and external), execution excellence, domain expertise, effective communication, developing organizational talent, and team leadership. By applying your expertise and knowledge, you will play a vital role in ensuring regulatory compliance and contributing to the success of Olympus Medical Systems India's regulatory affairs team.,

As a Regulatory Affairs Associate, you will be required to hold a Master's Degree in M. Pharm or M. Sc. with a specialization in Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, Biochemistry, or Microbiology. A minimum of 2 to 6 years of hands-on experience in R&D within Manufacturing or Import companies, specifically in MNCs and Generics, is essential for this role. Proficiency in CDSCO and Central Licensing Agency - New Delhi (SUGAM) skills, including Agency Liaison, is a priority as applications lacking these skills will not be considered. Your responsibilities will include understanding new client requirements, scope, deliverables, and timelines, reviewing and finalizing Gap Analysis Reports, effective collaboration and communication with internal and external stakeholders, technical writing of regulatory documents, liaison with licensing authorities such as CDSCO, training internal technical team members on the latest updates and guidelines, and coordinating with stakeholders. Key responsibilities will involve Regulatory Strategy, KOL/SME/Agency and Network-Access, Review of Documents/Dossiers and Gap Analysis, and Technical Writing of Regulatory Documents. This is a full-time position with a day shift from Monday to Friday, based in Bangalore (Cunningham Road), serving the Indian market for API and Finished Formulation. A willingness to travel up to 25% of the time is required, with a start date of 04/08/2025, and the application deadline is 07/07/2025.,

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.,

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana Interview Date:- 05-07-2025 @Saturday Interview Time :- 9AM TO 2PM Venue Details : MSN Laboratories Pvt. Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy Contact :- 9154811048 Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 1-7 years of regulatory affairs experience in the pharmaceutical industry. Key Responsibilities: Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations. Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals. Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance. Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required. Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities. Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations. Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management. Position : Executive Qualification : M.sc Work Location : MSN R&D Center, Pashamylaram. Department : API Regulatory Affairs Dept - ( API RA ) Experience : 1 to 7 Years Job Location : MSN Laboratories Pvt.Ltd., MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy Interested Candidates can share there CVs to dinesh.baratam@msnlabs.com

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization. Experience interacting with the FDA and other regulatory authorities. Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Key Result Areas/outputs Activities . Ensure that all licensing for assigned products is complete in accordance with relevant norms Monitor status of product licenses Manage changes in product licenses and coordinate with other changes, planned and in progress Maintain complete documentation records Communicate changes to licenses status promptly Develop and implement action regulatory plans for allocated products to achieve requisite approvals rapidly and facilitate rapid launch Maintain detailed knowledge of critical aspects of products: commercial strategies, the content of the dossiers, regulatory intelligence, regulatory timelines and supply strategy Ensure that local regulatory strategies are consistent with global product strategies and local priorities Develop regulatory plan in conjunction with key stakeholders and ensure allocation of adequate resources and deliver plans on time Track status and take prompt corrective measures whenever necessary to ensure rapid approval and launch Provide Leadership and direction within project teams Strive to ensure high levels of performance and achievements. Take decisions and accountability for actions. Build commitment within the team. Enhance positive attitudes and mindset. Demonstrate confidence and conviction. Challenge the status quo for continuous improvement. Help build an open and trusting atmosphere Assist in Issues. Interact with relevant regulatory authorities on a regular basis to facilitate the process of obtaining necessary approvals/permissions Monitor and understand the impact of external changes in the regulatory and political environment that will impact on the assigned products Communicate the impact of changes to key stakeholders. Influence key external stakeholders, in line with codes of conduct, to improve regulatory outcomes Develop excellent relationships and partnerships with Regulatory Authorities Competitive Intelligence and Analysis Monitor the global pipelines of competing pharmaceutical companies Analyse gathered the information for its impact on AstraZeneca s proposed pipelines Provide a scenario with options and a risk-benefit analysis for AstraZeneca going forward

Business: Piramal Pharma Solutions Department: CRA Travel: Moderate JOB OVERVIEW: Preparation of licenses application & filing them on governmental portals for approvals from Indian regulatory authorities required for manufacturing, marketing and export of products in domestic and overseas markets by PPL sites in India. KEY STAKEHOLDERS: INTERNAL: Manufacturing sites, R&D ,Program management, Supply Chain, Marketing, site regulatory KEY STAKEHOLDERS: EXTERNAL: Govt. authorities like State FDA, CDSCO, FSSAI, CBN, NCB, custom officials, Customers etc REPORTING STRUCTURE: (Reports To/ Direct Reports Y/N): Direct report to General Manager-RA ESSENTIAL QUALIFICATION: Graduate KEY ROLES/ RESPONSIBILITIES: KEY ROLES/RESPONSIBILITIES: Registration Application on various Government portals (CBN, Sugam, FSSAI & XLN India) for new user Ids creation. Follow up with State FDA Thane, CDSCO, FSSAI, NCB for grant of licenses Product Registration application in Form 41 on DCGI Sugam Portal. Written confirmation (WC) application on DCGI Sugam Portal for APIs. Preparation & Online Submission for Import License application in Form 10 Preparation & Online Submission for CBN permissions (Import Certificates & Quarterly return filling) Preparation & Online Submission of API, RLD Test License Applications (Form11 & Form CT 17). Preparation & Online Submission of CDSCO permission in Form CT-11, CT-14 & CT-15, Dual Use NOC & Export NOC Preparation & Online Submission of application on state FDA portals like Test Licenses (Form 29), wholesale license etc., Preparation & Online Submission of various CBN application (Import/ Export/Quota/Mfg. License). Quarterly return submission to CBN/NCB/State FDA Provide regulatory strategies and support all stakeholders w.r.t assessment of D&C Act Feedback on new guidance Review and assessment for selection of product for manufacturing at site as per the D&C act To create PR in SAP to process payment for various bills/Invoices received from consultants. KEY COMPETENCIES: written and spoken communications skills, cross functional collaboration, negotiation skills, meticulous planning and execution for timely receipt of approvals.

The RA CMC Senior Manager is responsible for execution and/ or coordination of global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of the regulatory strategy for an assigned set of commercial products. The RA CMC Senior Manager is responsible for communicating the regulatory strategy, risks and issues to Regulatory and Operations senior management. The RA CMC Senior Manager coordinates communication, collaboration, and coordination with the site and regional CMC representatives within the department to develop and execute global regulatory activities. The RA CMC Senior Manager may have staff oversite. Key Activities Contributes to product teams and acts as Global RA-CMC lead or supervisor for one or more products. Provides strategic regulatory input and regulatory risk assessments for product teams; executes regulatory strategy with respect to preparation of submissions. Complies with critical RA CMC processes; identifies need for process and strategy changes to meet internal Amgen initiatives and changes in external regulatory policy and guidance. Reports needs for process changes to CMC systems and contributes to process improvements. Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams. Reports issues to RA CMC product team management. May manage and develop junior staff. Key Responsibilities Include: Oversees deliverables for CMC strategy and submissions for an assigned portfolio of products at varying stages of development. Works with external stakeholders including regulatory agencies and influential professional bodies, and seeks to influence regulatory policy globally. Identifies regulatory risks across products within the defined scope, communicates these risks, and ensures aligned plans for mitigation. Provides coaching, mentoring, and supports development of junior CMC Regulatory Affairs staff. Provide CMC regulatory strategy for assigned projects by defining minimal regulatory filing requirements, submission strategy, and regulatory risk assessments. Develop response strategy and respond to health authority questions. Liaise with other functions in development, operations and commercial to ensure alignment of global regulatory strategies, timing, execution and supply plans. Liaise with local regulatory teams to align on filing strategy. Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current. Maintain submission information according to the Regulatory Information Management (RIM) system. Follow established department regulatory processes to ensure cross-product alignment. May manage staff. Knowledge and Skills Regulatory CMC-specific regulatory knowledge & experience Staff management and development Education & Experience (Basic) Doctorate degree OR Master's degree and 3 years of directly related experience OR Bachelor's degree and 5 years of directly related experience OR Associate's degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience Education & Experience (Preferred) Experience in manufacture, testing (QC/QA or clinical), or distribution Regulatory CMC experience

Regulatory Affairs Manager Devices What you will do Let's do this. Let's change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impact JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master's degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor's degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master's degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process 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

Manager - International Regulatory Lead Role Name Manager International Regulatory Lead (IRL) Department Name International Regulatory Team, Global Regulatory Affairs Role GCF5A ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. ABOUT THE ROLE Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to: optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans). Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio. Under general supervision, contributes to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate. Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing. Directs development of and manages the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes. Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management. Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams. Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations. Partners with peers to agree on product strategy including projected submission and approval time. Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status. Builds effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function. Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products. Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement. Basic Qualifications and Experience: Doctorate degree OR Master's degree and 3 years of relevant regional regulatory experience OR Bachelor's degree and 5 years of relevant regional regulatory experience OR Associate degree and 10 years of relevant regional regulatory experience OR High school diploma/GED and 12 years of relevant regional regulatory experience. Functional Skills: Must-Have Skills: Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they impact other projects and/or processes General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities. Good-to-Have Skills: Ability to resolve conflicts and develop a course of action leading to a beneficial outcome Cultural awareness and sensitivity to achieve results across country, regional and international borders. Soft Skills: Strong communication skills, both oral and written Ability to understand and communicate scientific/clinical information Ability to work effectively with global, local and virtual teams High degree of initiative and self-motivation Planning and organizing abilities Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Good negotiation and influencing skills.

Role: Project Corporate Affairs Support - Deputy Manager Department: Corporate Affairs Location: Umrongso, Dima Hasao, Assam Qualification: MBA / MSW / LLB Job description: Support in executing the organizational growth & transformation goals, and protect & promote the reputation of the business in the region Minimize expenditure through effectively managing the departmental budget whilst consistently identifying and initiating cost saving initiatives Liaise with relevant departments in the region to ensure mitigation of regulatory risks by way of identifying, assessing and creating mitigation plans for the same Responsibility to manage PR and represent DCBL in front of various external stakeholders as per business requirements Focus on building sustainable relations at political, bureaucratic & other administrative levels Liaise with govt departments and local bodies as for matters pertaining to laws and adherence to legal requirements Co-ordinate with various departments to timely file claims and speedy processing of the incentive proposals Stay updated on the key happenings, movements, and other developments in the region and share relevant information's to Regional Corporate Affairs Head