Department:
Regulatory Affairs
Experience:
3-12 years
Qualification:
M.Pharma / M.Sc / B.Pharma
Job Location:
Bangalore
Role
Formulation Regulatory Affairs – US/Canada Market: Pre-Approval
Managing pre-approval activities for products intended for the US/Canada market, including deficiency management and change control assessment.
Formulation Regulatory Affairs – US/Europe Market: Post-Approval
Handling post-approval activities for products in the US/Europe market, such as submission of supplements/variations, PADER/PSURs, annual reports, deficiency responses, and life cycle management.
Formulation Regulatory Affairs: Emerging Markets
Expertise in registration processes for various emerging markets, addressing queries, and managing post-approval life cycle.
API Regulatory Affairs: DMF Filing/Submission
Managing Drug Master File (DMF) submissions globally, handling customer queries, post-approval changes, and providing regulatory insights.
Key Skills
- Proficiency in US/Canada Market regulations, with expertise in deficiency management.
- Timely preparation and submission of supplements/variations, PADER/PSURs, annual reports, and handling post-approval deficiency responses.
- Registration experience in diverse emerging markets, adept at life cycle management post-approval.
- Expertise in DMF submission globally, addressing customer queries, managing post-approval changes, and offering regulatory guidance.
Job Location:
Bangalore
Walk-in Interview
Date: 5th May 2024, Sunday
Time: 9:00 am to 2:00 pm
Venue: Hotel Lemon Tree Premier, HITEC City, Madhapur, Hyderabad – 500081, Telangana
Interested candidates can email their resumes to upendra.kamma@biocon.com / rashmi.gupta@biocon.com for an interview opportunity.
