Regulatory Affairs Expert
hace 2 semanas
Company Overview
Teva Pharmaceuticals is a global leader in the development and production of generic medicines, with products listed on the World Health Organization's Essential Medicines List.
We are committed to making good health more affordable and accessible to millions worldwide, through our mission to improve lives.
Job Description
We are seeking an experienced Regulatory Affairs Associate II to lead and manage all regulatory activities associated with drug development, registration, and maintenance. The ideal candidate will have strong knowledge of international regulatory requirements and be able to coordinate DMF preparation and related activities for On-Time Submissions across various markets.
Key Responsibilities
- Support the life cycle management of APIs from a RA perspective
- Review and approve ROS, specification, and analytical control when required
- Coordinate pre-launch activities from a RA perspective
- Manage the regulatory aspects and related tasks of assigned commercial APIs
- Evaluate change requests and address submissions per market to support changes
- Maintain up-to-date DMFs according to regulations
- Support customers with Service Requests, providing professional information in a timely manner
Requirements
To succeed in this role, you will need:
- Conversational English and at least 5 years of experience in RA
- High degree in a relevant field (chemistry/biochemistry/biology or biotechnology)
Benefits
Teva Pharmaceuticals offers a competitive salary and benefits package, including:
- A base salary of $80,000 - $110,000 per annum, depending on location and experience
- Ongoing professional development opportunities
- A dynamic and inclusive work environment
About Teva Pharmaceuticals
Teva Pharmaceuticals is committed to equal opportunity in employment and strives to create a diverse and inclusive workplace. If you require accommodations during the recruitment process, please advise us accordingly.
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