Manager – Regulatory Biologicals
Business Unit:
GDO
Job Grade
G10
Location :
Gurgaon/Mumbai
At Sun Pharma, we commit to helping you “Create your own sunshine” — by fostering an setting 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.

📌 Manager -Regulatory Affairs-Biologics (Gurugram)
🏢 SUN PHARMA
📍 Gurugram