Regulatory Affairs Specialist
- Company
- Barrington James
- Location
- Eindhoven (Gemeenten), Noord-Brabant (NL)
- Salary
- Up to €65,000
- Posted
- 12 Jan 2021
- Closes
- 11 Feb 2021
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Entry level
Regulatory Affairs Specialist
The regulatory specialist will manage all the regulatory requirements Advanced Therapy Medicinal Products. The key responsibilties will be writing and reviewing IMPD and IND submissions to support clinical trials, regulatory authority communications, contributing to regulatory strategy, providing regulatory guidance to project teams and project management.
Job Responsibilities:
Depending on experience the regulatory specialist will be responsible for EU and/or US regulatory activities to:
• Draft, review and maintain regulatory submissions in support of ATMP clinical trials (IMPD/IND).
• Support the timely responses to questions and other regulatory authority communications (e.g. Scientific advice (EMA/FDA) orphan drug requests and annual reporting, PRIME applications, etc.).
• Support the development of global regulatory strategies and implementation plans for the preparation and submission of new products, ensuring regulatory project timelines are aligned across all departments
• Provide regulatory support/guidance to cross functional teams and stay up to date with relevant guidance and regulations ensuring timely communication of changes.
• Support the regulatory release of products to clinical trials and assessment of changes.