Regulatory Affairs Specialist

☞ Prime Life Sciences

View: 188

Update day: 25-03-2024

Location: Basel Basel-Stadt BS

Category: Legal / Contracts

Industry: Medical Devices Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

Loading ...

Job content

To strengthen our team in Switzerland, we are looking for a Regulatory Affairs Specialist who will support the site’s and customers’ regulatory affairs and CMC project activities. In this role, you will provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues.

Your Duties

  • Regulatory document writing for clinical and market authorization, especially module 3
  • Variation dossier and regulatory affaires maintenance during all the product life
  • Interface with health authorities during all the product life
  • Ensure compliance of the company’s processes with regulations
  • Support the organization by providing regulatory expertise
  • To be proactive on the regulatory strategy
Our Requirements

  • Master or PhD degree in pharmacy or chemistry or biotech
  • First experience of writing parts of the module 3 for chemical or biologic products
  • Additionnal education on Regulatory Affairs is a plus
  • Fluent in English, German is a plus
Are you looking for a new challenge and want to be part of a dynamic, multifaceted and multicultural team? So, we are looking forward to receive your application.
Loading ...
Loading ...

Deadline: 09-05-2024

Click to apply for free candidate

Apply

Report job
Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...