Title:  Senior Manager -Regulatory Affairs-Biologics

Job Title:

Sr. Manager – Regulatory Biologicals

Business Unit:

GDO

Job Grade

G9

Location :

Gurgaon/Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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 biologicals 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
• Compiles, prepares, and reviews 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:

• Should have handled the successful regulatory submissions for novel biologics / biosimilars for developed markets and Row markets
• Should be able to evaluate the technical information required to build zero defect dossiers of biological products for IND, NDA, BLA and MAA for various markets
• Hands of expertise of preparation & review of dossiers, response to queries, communication with agencies for developed markets like US/EU

• Excellent communication skill in orating and narrating the regulatory requirements and scientific rationale to negotiate with internal and external stakeholders
• Demonstrate sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

Leadership Skills:

• Demonstrated ability to lead and mentor the regulatory CMC teams for the international expansion of the established medicines.
• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
• Demonstrated effective leadership, communication, interpersonal and negotiating skills.

Education Minimum Requirement:

• 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  
• This role needs a regulatory expert with hands on experience on regulatory activities for NDAs / BLAs, who has the management capability of leading a group of team members
• Preferable to have extensive knowledge in development, manufacture, testing and release of the biotechnology products.
• The candidate must be proficient in English; additional language skills are a plus.
• Good inter-personnel skills with ability to direct multi-departmental functions.

Travel Estimate

Job Requirements

Educational Qualification

 Master’s degree preferred.

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).