Biologics Regulatory Affairs Specialist
2 days ago
Biologics Regulatory Affairs Specialist (Clinical Trials)
About the Role:We are seeking a skilled Biologics Regulatory Affairs Specialist to oversee the regulatory aspects of our clinical trials for EU and US markets.
The ideal candidate will have hands-on experience in developing biosimilar clinical development strategies, clinical trials, and injectables for these markets.
Key Responsibilities:- Developing and implementing biosimilar clinical development strategies, including clinical trials and injectables for EU and US markets.
- Designing and finalizing biosimilar clinical protocols for EU and US markets.
- Overseeing the clinical trial application process, reviewing and finalizing clinical study reports for EU and US markets.
- AUTHORING AND REVIEWING BIOLOGICS/BIOSIMILAR DOSSIER SUBMISSIONS for EU and US markets.
- Responding to MOH queries.
- Managing product lifecycle activities.
- Providing regulatory support for plant-related QMS activities.
- Hands-on experience in biologics regulatory affairs.
- Strong understanding of EU and US regulatory frameworks.
- Excellent communication and project management skills.
- Ability to work independently and as part of a team.
We offer a competitive salary package, opportunities for growth and development, and a dynamic work environment.
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