Regulatory Affairs Specialist

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.

Apply for Regulatory Affairs Specialist

Already uploaded your CV? Sign in to apply instantly

Apply

Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from PharmiWeb.jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs