Research Manager

Job Title

API Regulatory Affairs

Business Unit

Sun Global Operations

Job Grade

G11B/G11A

Location:

GurgaonAt 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

• To review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updating to meet current regulatory requirements.
• To review outsourced intermediates and APIs for regulatory adequacy to support Procurement Team in vendor selection and DF-Regulatory for ANDA/MA submission.
• To coordinate & support Chemical Research Department, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies for regulatory submissions as well as for responding regulatory queries.
  

To ensure reposition of API dossiers into central repository and to provide information about regulatory commitments in timely manner.

Deliverables

• Compilation and review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs and ensuring their updating.
• Preparation and review of Regulatory Amendments / Variations for smooth API supplies
• Preparation of responses to regulatory deficiencies
• Regulatory support to Chemical Research Department, Analytical Department, Chemical manufacturing, Quality Assurance, Procurement Team and Regulatory Affairs-Pharma
  

Ensure reposition of regulatory database and compliance to departmental guidelines.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc. (Organic chemistry)/M. Pharma (Medicinal Chemistry)

Experience

Tenure : 7 to 14 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).