Opportuntiy to work as Regulatory Affairs Associate at Teva- Apply Before 30th November 2023

About Teva

Teva Pharmaceuticals is recognized as the largest producer of generic medicines worldwide, dedicated to enhancing health and expanding the availability of high-quality healthcare solutions on a global scale. The company’s success is fundamentally attributed to its workforce, comprising individuals across more than 80 countries. Together, these employees contribute to delivering a vast array of medications to 200 million individuals daily, effectively establishing the world’s most extensive collection of medicines. Teva’s offerings encompass a distinctively varied range of products and remedies tailored to meet the needs of patients. The company’s focus is underpinned by a promising pipeline of innovations concentrated in its core therapeutic domains.

Post: Regulatory Affairs Associate I

Job Description

Responsibilities:

• RA Lifecycle Management: Project manager (PM) role for Medis dossiers on behalf of Teva’s 3rd party client business (Medis), ensuring seamless information flow and provision of supporting documents to clients.
• Liaison: Act as a liaison between Teva’s 3rd party client business (Medis), supply chain, Teva site RA, and other relevant functions.
• Product Lifecycle Management: Manage specific products for the European and international markets.
• Regulatory Modules: Ensure that regulatory modules under Product Manager responsibility are always up-to-date, following agreed-upon procedures.
• Variations: Inform, prepare, and submit variations to authorities or Teva’s 3rd party client business (Medis).
• Follow-Up: Monitor variation submissions, timelines, and approvals, adhering to established procedures.
• Deficiency Responses: Compile answers to any deficiency questions from authorities or clients.
• Communication: Ensure timely communication of variation outcomes and maintain up-to-date databases/lists according to agreed procedures.
• Reporting: Provide regular status updates to management and participate in goal setting and follow-up with supervisors.
• Specialized Projects: Work on other specialized projects as defined by RA managers.

Candidate Profile

Qualifications and Experience:

• M.Pharm/M.Sc: 2-3 years of regulatory affairs experience.
• B.Pharm/BSc: 5+ years of regulatory affairs experience.

Additional Information

• Experience: 3+ years
• Qualification: M.Pharm, B.Pharm, M.Sc
• Location: Navi Mumbai
• Industry Type: Pharma/Healthcare/Clinical Research
• Job ID: 52304
• End Date: 30th November 2023
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