Sun Pharmaceuticals Pvt. Ltd Walk In Interview 2023. Sun Pharmaceuticals Pvt. Ltd Notification full details below. Interested and eligible candidates can attend interview on scheduled time and venue. From humble beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Our passion for research has enabled us to develop over 2000 products that are sold in more than 100 countries worldwide.
Vacancy details:
- Department: R&D – Biotechnology – Upstream Process/Regulatory Affairs – Branded
- Post Name: Executive / Sr. Executive/Manager / Sr. Manager
- Qualification : M.Tech / M.Sc / PhD – Biotechnology or Biochemistry/M.Pharm / M.Sc in Biotech
Job Description: Greeting from Sun Pharmaceuticals Pvt. Ltd !!!!!
Important Details :
- Location: Baroda / Mumbai / Gurgoan
- Post of date:14/04/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Fact to face Interview.
- Rounds of Interview: HR
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 regulatory submissions 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:
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 biosismilars.
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
