Senior Manager -Regulatory Affairs-Biologics

Career Opportunities: Senior Manager -Regulatory Affairs-Biologics (59595) Requisition ID 59595 -Posted - ALL - India Job Responsibilities Responsible for developing, executing, and maintaining the regulatory requirements for biologicals, as well as managing regulatory commitments Stay abreast of regulatory agency regulations, directives, guidelines, and policies for biologics that could impact product development, in order to assess approval pathways and identify potential issues Ensure lifecycle management through the timely submission of annual reports, supplements, etc., to maintain product continuity. Support the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity Provide regulatory support, as needed, in product in‑licensing/due diligence reviews, product divestments, and product withdrawals. Manage the execution of regulatory documentation, including PIND/IND/IMPD/CTA, original BLA/MAA, agency background packages, and responses to health authority questions, in accordance with established business processes and systems. Set and monitor submission timelines in collaboration with key stakeholders. Coordinate with global manufacturing sites and integrate regulatory strategy across those sites. Provide consistent support to cross‑functional teams such as commercial and clinical teams. Ensure communication with regulatory authorities is conducted in accordance with established departmental procedures. As applicable, review audit reports, regulatory agency inspection reports, and responses to inspection observations, if any, upon receipt Compile, prepare, and review regulatory submissions to regulatory agencies, as applicable. Conduct department‑level training, as necessary, to educate regulatory strategists and other roles within the department on regulatory requirements, policies, and procedures. Participate in the authoring and/or review of departmental procedures/guidance, as applicable. Technical Skills Handled successful regulatory submissions for novel biologics/biosimilars for developed and emerging markets Evaluated technical information required to build zero‑defect dossiers of biologic products for IND, NDA, BLA and MAA across various markets Expertise in preparation & review of dossiers, response to queries, and communication with agencies for developed markets such as US/EU Excellent communication skill in presenting regulatory requirements and scientific rationale to negotiate with internal and external stakeholders Strong understanding of related fields (e.g., manufacturing, analytical, quality assurance) and ability to be creative and imaginative in problem‑solving approaches Leadership Skills Demonstrated ability to lead and mentor regulatory CMC teams for international expansion of established medicines Demonstrated flexibility in responding to changing priorities or dealing with unexpected events Demonstrated effective leadership, communication, interpersonal and negotiating skills M‑Pharm in pharmaceutical sciences / M.Tech – Biotechnology / MSc – Life sciences Required Experience and Skills 10‑15 years of hands‑on experience in regulatory affairs Regulatory expert with hands‑on experience on regulatory activities for NDAs/BLAs, managing a group of team members Preferable to have extensive knowledge in development, manufacture, testing and release of biotechnology products Proficient in English; additional language skills are a plus Good interpersonal skills with ability to direct multi‑departmental functions Educational Qualification Experience Tenure 12+ years Your Success Matters to Us At Sun Pharma, your success and well‑being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together! Disclaimer The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). #J-18808-Ljbffr