POSITION - Deputy Manager - RA (Formulation)

LOCATION - Hyderabad

QUALIFICATION - M.Sc. or M. Pharm

EXPERIENCE - At least 8 to 9 years of experience in global regulatory affairs department (USA, EU, Canada, Australia)

CTC RANGE - 12 LPA

JOB DESCRIPTION - 

1. Lead product registrations (formulation and APIs) in global markets (USA, EU, Canada, Australia, India, others).

2. Regulatory strategy design, preparation, gap analysis of submission documents and authoring technical reports for cross functional teams.

3. Pre-submission advice on CMC, labelling and Bio studies to CFTs (R&D and Plant).

4. Timely submission of effective response to the queries from regulatory authority in coordination with CFT.

5. Post approval submission management activities for approved products.

6. Risk assessment, troubleshoot and resolve the anticipated regulatory issues.

7. Active participation in regulatory inspection preparation and represent the regulatory function.

8. Advise/guide on end-to-end regulatory activities related to global market applications.

9. Mentor juniors, conduct training sessions on the latest regulatory advances and requirements to the team.

10. Experience on the renowned software’s to be utilized in regulatory submissions for eCTD format.

11. Systematic process development of policies and procedures for Global market registrations.

12. Relationship management with cross functional teams and external regulatory service partners. 

   

At least 8 to 9 years of experience in global regulatory affairs department (USA, EU, Canada, Australia, India, others) of any top pharma companies.

Contact No & WhatsApp - 9737979902

Mail ID - hiring@bigpharmajobs.co.in/ workfromhome.virendra@gmail.com