Sun Pharma Hiring For Regulatory Affairs/ R&D - Biotechnology Upstream Process

Sun Pharmaceutical Industry Limited

1) Opening in Regulatory Affairs - Branded

Qualification: M.Pharm/ M.Sc in Biotech

Grade: Executive / Sr. Executive

Job Location: Baroda / Mumbai / Gurgoan

JOB DESCRIPTION:

1) This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for licensed biologic products across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.

2) Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatorysubmissions are on time and high quality.

3) Understanding country specific requirements, particularly for EM, and sharing additional data generation/gap assessments with CFT

4) Closely work with consultants, partners and local regulatory colleagues to understand regional requirements.

5) Preparation of Agency consultation packages, briefing book and required presentations and engage with Agency for consultations

6) Provide CMC support for other branded projects as needed.

7) Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.

8) Responsible for preparation of IND and IMPD documents

9) Providing consistent support to commercial and clinical teams.

Send in your resume to: Rosemary.varghese@sunpharma.com

Sun Pharmaceutical Inds Limited - Baroda:

2) Opening in R&D - Biotechnology Upstream Process

Grade: Manager/Sr. Manager

Qualification: M.Tech/M.Sc / PhD - Biotechnology or Biochemistry

Job Location: Baroda

Brief JD:

1) Planning of lab scale studies for development, optimization and characterization of upstream process.

2) Exposure to Global market requirements related to biosimilars.

3) Participating in project planning, including timelines and resources for internal and CDMO projects.

4) Supporting GMP manufacturing during scale-up, technology transfer and through process investigations, deviations and change control assessments.

5) Seeking and identifying improvement and optimization of the process with regards to technical as well as economic aspects

6) Collaboration with DSP, analytical, PM, QA/QC, Regulatory, IP and external CDMO clients in order to achieve results.

7) Supporting all activities related to setting up process development lab with good laboratory practices and organizational and safety standards.

8) Good exposure for CMC support for global biotech product filing.

9) Upstream MSTG experience is desirable.

Send your resume to: Rosemary.varghese@sunpharma.com

Freshers need not apply

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