Teva Pharma Regulatory Affairs Job – Apply Online
Regulatory Affairs Associate II
Date: Jan 22, 2024
Location: Goa, India, 403722
Company: Teva Pharmaceuticals
Job Id: 53695
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
- Assess submission documentation in consideration and compliance with the regulatory requirements and to provide inputs to cross functional teams.
- Coordinate (on need basis) with external parties and cross functional teams to obtain essential scientific data and documents required for regulatory submissions.
- Responsible to compile the CMC (m2 & m3) dossier and post approval supplements (on need basis) primarily for EU, also further supporting other Ex-North America filings in CTD format as per the submission timelines.
- Support due diligence process pre-filing and implement action plan to address deficiencies.
- Handling of Deficiency letters from regulatory authority’s until product approval.
- Escalate key issues to management (risk of delays to submissions, risk to approvability, complex supporting data requirements).
- Assist submissions team with CMC related m1 administrative documentation.
Your experience and qualifications
- Graduation/Post graduation in Science/Pharma discipline
- Minimum 3+ Yrs in core pre-approval regulatory activity in EU and allied markets for Solid Oral Dosage forms. Preference for additional experience in formulation/analytical development.
Sr Manager – Regulatory Affairs
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