Regulatory Affairs Specialist

Eindhoven (Gemeenten), Noord-Brabant (NL)
Up to €65,000
12 Jan 2021
11 Feb 2021
Regulatory Affairs
Full Time
Contract Type
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.

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