Regulatory Affairs Job at Teva | M Pharm Graduates Apply Now
Teva Pharmaceuticals, the world’s leading manufacturer of generic medicines, is looking for a motivated Regulatory Affairs Associate I to support post-approval regulatory activities for European markets. This Regulatory Affairs Job focuses on preparing high-quality submissions, maintaining compliance for EU procedures, and ensuring timely approvals, contributing directly to Teva’s mission of delivering accessible and affordable healthcare to millions worldwide.
- Position: Regulatory Affairs Associate I
- Location: Navi Mumbai, India, 400706
- Job ID: 64984
About The Company
Teva operates across nearly 60 countries, supplying medicines trusted by over 200 million people every day. With a strong heritage in generics and a growing portfolio of innovative products, Teva continues to push boundaries in global healthcare through science, collaboration, and purpose-led work.
The opportunity
- To organize and perform required regulatory tasks to maintain existing EU procedures in line with current regulations, guidelines, and in-house standards.
- To obtain regulatory approvals for defined European procedures, ensuring high-quality data and standards are used in all regulatory applications.
- To ensure high-quality documents and standards are used in the preparation of all regulatory applications to achieve rapid and successful assessment.
- To give regulatory support to project teams, stakeholders, and other sites as required.
Responsibilities of the MPharm Job
- Prepare, compile, review, and submit high-quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
- Responsibility for MA compliance with both legislation and business needs.
- Prioritize, plan, and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
- Ensure approvals are secured within the stipulated timelines for designated projects.
- Maintain registration documentation and associated electronic databases, in line with in-house procedures.
- Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
- Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines.
- Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
- Awareness of regulatory legislation and guidelines.
Your experience and qualifications
- Required Degree: M Pharm
- Total years of experience required for the role: 2 to 3 years in Post approval Regulatory affairs.
- Overall Pharma industry experience: 2 to 3 years.
- Desirable to have EU experience and knowledge of European regulatory procedures.
Knowledge and Skills for the MPharm Job
- Desirable to have EU member state experience and knowledge of European regulatory procedures.
- Understanding of processes and departments within a pharmaceutical company.
- Excellent oral and written communication.
- Ability to work under pressure and to tight time deadlines.
- Effective time and organisation management.
- Negotiation.
- Initiative.
- Analytical (Data and Documentation).
- Computer literacy.
- Teamwork and collaboration.
- Attention to detail.
- Planning and Organisation.
