Quality Healthcare for the betterment of humankind
As the world moves ahead, there’s one thing that fuels growth towards a better tomorrow – good health. VSI is a specialty healthcare ISO 13485: 2012 certified company and EU- GMP certified manufacturer that strives for better health for people by bringing them international quality healthcare and pharmaceutical products.
Job Description
Department: Regulatory Affairs
Role: Assistant Manager / Sr. Executive
Qualification: B.Pharma in Pharmacy
Experienced: 05 to 10 years
Salary: ₹ 4,00,000 – 7,00,000 P.A
Location: Mumbai (All Areas)( Worli )
Roles and Responsibilities
- Handling dossier related submission, lifecycle of registered products and queries
- Managing the team to resolve these queries in a timely manner
- Interacting with the other HODs and staff at plant and marketing on important issue related to registrations and data availability and projects.
- Maintaining the monthly repository of registered products, ongoing registration and queries.
- Liasoning with Marketing and customers to push for registration and queries and overseas requirements for products.
- Scheduling meetings and training sessions, or online coaching of team with ongoing activities.
- Due diligence and GAP analysis of dossiers for extension to other markets.
- Due diligence of Bioequivalence requirements for different markets.
- Liasoning with purchase on CDA and drug master files.
- Providing input on the quality agreement where required
- Managing overall artwork and labelling requirements for different countries and regions.
- AMV and pharmacovigilance related activities.
- Strategy for participation in tenders with Marketing
- Interacting with Regulatory agencies of various countries for scientific inputs and product specific
Interest Candidate may apply on:–gita.hr@vsinternational.co.in
please provide your below details:-
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