Rusan Pharma is hiring in Regulatory Affairs. Rusan Pharma Ltd. is a fully integrated global pharmaceutical company specializing in the treatment of ‘Addiction and Pain Management’.Application form link provided at the end of post. Eligibility for the Regulatory Affairs – API as follows.
Vacancy Details :
- Company Name: Rusan Pharma
- Location : Mumbai
- Post Name: Regulatory Affairs – API
- Department: Regulatory Affairs
- Qualification: B.Sc / M.Sc / B Pharm / M Pharm
- Experience:2-07 yrs
- No of Vacancies: Details not provide by recruiter
- Details of Salary: Details not provide by recruiter
- Contact: 022 42383000 / 42383063, 022 28682512/15
- Mode of application : Online
- Selection Process: Personal interview
Job Description/Skills Required :
Maintenance of the complete history of each API (Filing history with agencies/customers, amendments, annual reports).
Taking approval of customers of API before implementing any major changes regarding the information mentioned in DMF/ASMF/Dossier. The updated DMF/ASMF may be submitted to the customer simultaneously along with amendments/variations filed with the agency.
Review of Batch records, specification, analytical method validation documents, and development documents.
Ensure adherence and compliance with all the applicable cGMP, ICH, GCP, GLP guidelines, regulations.
Providing expertise and regulatory planning for resolving regulatory requirements into practical workable plans
Job Location :
Rusan Pharma Ltd.
58-D, Government Industrial Estate,
Babrekar Nagar, Next to Gas Gas Company
Next to IPCA RD centre, Charkop,
Kandivali (W), Mumbai 400 067
Board Line: 022 42383000 / 42383063, 022 28682512/15