Sentiss is committed to providing the best quality pharmaceutical products primarily in the Ophthalmic, ENT and Inhalation segments.
Job Title : Sr. Executive – Regulatory Affairs
Location : Gurgaon
Experience : 3 – 5 Years
Salary: INR 2,00,000 – 5,00,000 P.A.
Job Description:
- To co-ordinate for all inputs required in finalizing registration/re-registration dossiers for various countries as per the requirement and review the same.
- To prepare and compile the registration/re-registration dossiers & amendments for submission in US / EU
- Handling of queries related to registration and re-registration of product
- To review plant documents, R&D documents & periodic review documents
- To handle internal audit
- To provide technical guidance to other team members
- Preparation and revision of departmental SOPs
- To review Drug Master Files
- Co-ordinate for samples and standards for registration/re registration of product
- To review and sign off bilingual COAs
- Keep HOD up-to-date on status of specific project.
Qualification : PG – M.Pharma – Pharmacy