Regulatory Affairs Specialist
3 weeks ago
At BTA, we are seeking a highly skilled Regulatory Affairs Specialist to join our International Regulatory Affairs Team in London, UK.
The successful candidate will be responsible for providing regulatory support for development programs or marketed products, contributing to the development of regulatory strategies for development and commercialization of programs within our portfolio.
Key Responsibilities:
- Develop and implement regulatory strategies as a member of the International Regulatory Affairs Team
- Develop proficiency in regulatory skills and support regulatory strategy under guidance of the International Regulatory Lead
- Manage regulatory communications with local health authorities and lead regulatory interactions under supervision
- Identify regulatory requirements for development and approval pathways for assigned regions
- Manage the process for preparation, submission, and approval of regulatory applications
- Provide technical regulatory input for key product development or registration documents
- Inform regulatory affairs senior management on the status of regulatory strategies and tactics, procedures, and practices
- Ensure compliance of regulatory submissions with current regulations and guidance
- Review regulatory intelligence and guidance information to continuously support regulatory strategy
Requirements:
- Doctoral degree in a scientific background and thesis defense
- Ability to assess and understand complex scientific information
- Strong problem-solving skills and written and verbal communication skills
- Ability to work effectively within a team environment and plan, prioritize, and contribute to work and projects in a systematic and efficient manner
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