Hiring In Regulatory Affairs@Teva Pharmaceuticals-Apply Now

About Company

Teva Pharmaceuticals is committed to making good health more affordable and accessible. As the leading manufacturer of generic medicines, Teva impacts the lives of millions globally with a rich diversity of nationalities and backgrounds. Their products are on the World Health Organization’s Essential Medicines List, serving at least 200 million people every day.

Position Name :Regulatory Affairs Associate I

Organization :Teva Pharmaceuticals

Qualification:B.Pharm, M.Pharm, Msc

Experience:2-5 years

Salary:25,000 – 35,000 /month

Location:Bangalore

Regulatory Affairs Associate I

Company: Teva Pharmaceuticals

Job ID: 55405

Location: Bangalore, India, 560064

Application Link

Key Responsibilities:

Dossier Evaluation: Assess dossier suitability for specific territories.
Regulatory Strategy: Prepare and submit MAAs to Medis clients.
Client Support: Engage actively and provide extensive support to Medis clients to facilitate MA approvals.
Liaison Role: Act as the primary contact between R&D, Site RA, Clinical team, Medis clients, and other relevant functions.
Timeline Monitoring: Coordinate and manage the flow of information internally and externally throughout the registration process until MA approval.
Regulatory Guidance: Offer guidance and support to Medis.
Database Maintenance: Maintain databases and other document management systems/lists.
Special Projects: Contribute to specialized projects as directed by Medis RA managers.
Dossier Audits: Organize dossier audits and due diligence for clients.
Status Updates: Provide regular status updates to management.

Qualifications and Experience:

Educational Background: B.Pharmacy, M.Pharmacy, or MSc in Chemistry.
Regulatory Expertise: Extensive expertise in global regulatory strategies.
Regional Knowledge: Strong skills and in-depth understanding of regulatory environments across various regions, including LATAM, Canada, China, etc.