Senior Regulatory Affairs Specialist
Vor 6 Tagen
Regulatory Affairs and Clinical Development Opportunity
Barrington James Limited is seeking a highly experienced Senior Regulatory Affairs Specialist to join our team in a key role that will provide strategic guidance and expertise to development teams working on a variety of cutting-edge projects.
About the RoleThis matrix-structured position will involve providing strategic regulatory advice and support to project teams, overseeing all clinical development aspects within project teams, developing and executing a comprehensive global regulatory plan, and leading the development and implementation of the global agency interaction strategy.
Key Responsibilities:- Offer strategic regulatory advice and support to project teams, ensuring compliance with regulatory requirements and industry standards.
- Oversee all clinical development aspects within project teams, including pre-clinical research, clinical trials, and regulatory submissions.
- Develop and execute a comprehensive global regulatory plan, ensuring alignment with business objectives and regulatory requirements.
- Lead the development and implementation of the global agency interaction strategy, building and maintaining relationships with regulatory authorities.
Advanced degree in life sciences, medicine, or veterinary medicine. Minimum of 10 years of experience in pharmaceutical development, with a proven track record in strategic clinical development and regulatory affairs. Experience working across different pharmaceutical companies and/or regulatory authorities is highly desirable. Excellent communication and interpersonal skills, with the ability to explain complex development scenarios. Strategic thinking, solution-oriented approach, and strong problem-solving skills. Ability to work independently, manage multiple tasks under pressure, and prioritize effectively. Experience with EU and US regulatory procedures is preferred.
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