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.
