Hetero Drugs Limited is Hiring For Assistant / Manager – Regulatory Affairs and has issued notification to accept Applications. Hetero Drugs Limited Limited. Limited is one of India’s generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Application form link provided at the end of post.
Vacancy summary details :
- Company Name: Hetero Drugs Limited
- Location : Mumbai
- Post Name: Assistant / Manager – Regulatory Affairs
- Qualification: B.Pharma , M.Pharma
- Experience: 6 to 10 year(s) of Experience
- No of Vacancies: NA
- Details of Salary:NA
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
1. Brief knowledge about MAs/ Formulation dossier filings of Drug products for successful approvals in ROW markets particularly AFRICA continent
2. Adequate knowledge of eCTD submission of formulated dossiers
3. Review and approval of Technology Transfer Documents / Site documents of New products, new projects
4. Close Coordination & follow up with internal & external stake holders for fast track submissions & approvals
5. Response to regulatory authority notices and quarries in time
6. Assist plant teams in regulatory audits, liaison with domestic & export regulatory authority.
7. Packing material (Art – work) recommendations and approvals as per regulatory provisions.
8. Ability to handle special & time bounded projects effectively
9. Ability & competency in handling external regulators directly
10. Willingness to travel abroad to interact with FDA regulators directly to bridge the gaps & to resolve issues.
Click here for notification and Apply
