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Regulatory Affairs Specialist
2 months ago
About the Role
We are seeking a highly skilled Regulatory Affairs Associate to join our team at Teva Pharmaceuticals. As a key member of our EU Regulatory Affairs department, you will play a critical role in supporting the submission of new marketing authorization applications and post-approval variations for our generic medicines.
Key Responsibilities
- Collaborate with R&D colleagues to ensure dossier technical content is optimal and aligned with EU regulatory data requirements.
- Perform regulatory activities for assigned projects, including review and optimization of dossier content, compilation and submission of files, and resolution of health authority questions.
- Ensure timely submission and approval of files and responses.
- Communicate regulatory information for assigned projects and provide regulatory support to project teams, stakeholders, and customers.
- Track and monitor queries, deficiency letters, and commitments from European health authorities.
- Ensure compliance with departmental and company SOPs and maintain accurate and complete internal tracking tools and databases.
Requirements
- Pharmacy, Chemistry, or Life Sciences degree.
- Regulatory Affairs experience, ideally with medicines, medical devices, or OTCs.
- Knowledge of pharmaceutical and scientific processes, regulatory requirements, and procedures.
- Excellent internal and external communication skills, as well as collaboration skills.
- Good attention to detail and time management skills.
What We Offer
- A dynamic and supportive work environment.
- Opportunities for professional growth and development.
- A comprehensive benefits package, including annual leave, hybrid working, and pension scheme.
- Recognition programs to reward employees with our company bonus scheme.
- Access to our Virtual Learning Centre.
