Executive​/Senior Executive - Regulatory Affairs - US Market

Position: Executive/ Senior Executive - Regulatory Affairs - US Market
Job Title

Executive - RBC

Business Unit

RBC

Job Grade

G12A/11B

Location :

Gurgaon

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.'

Key Responsibilities

Support and manage regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for licensed and clinical biologic products.
Provide strategic input into product development and offer regulatory direction to commercial and clinical teams.
Ensure the established regulatory strategy is aligned with global Health Authority requirements, and that all regulatory submissions are timely and of high quality.
Coordinate with global manufacturing sites to integrate regulatory strategy and communicate updates to senior management.
Provide regulatory support for additional CMC projects as required.
Prepare Agency consultation packages, briefing books, and required presentations, and engage with regulatory agencies for consultations.
Manage filing activities, including query responses and post-approval changes, for global products.
Conduct reviews as per US & EM requirements and share additional data generation requirements with the Cross-Functional Team (CFT). Bottom of Form

Travel Estimate

Job Requirements

Educational Qualification

M.Pharm

Experience

Tenure : 2 to 4 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).