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Global Regulatory Affairs Associate, Fast Growing

vor 3 Wochen


Basel, Schweiz Stratpharma Vollzeit

Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.

This is a highly successful company who have an impressive 200% year on year growth and are going through significant expansion. They currently have 8 products on the market but have a further 5 more products in development.

As a Global Regulatory Affairs Associate, you will play a crucial role in ensuring compliance with regulatory requirements and supporting the global registration and approval process for Stratpharma's products.

**Responsibilities**:

- Manage and maintain product registrations and submissions for global markets
- Prepare and review regulatory documentation and technical files
- Communicate with regulatory agencies and authorities
- Monitor and stay up-to-date on relevant regulatory changes and requirements
- Contribute to the development and implementation of regulatory strategies
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements

**Requirements**:

- Minimum 3 years of experience in Regulatory Affairs within the Medical Device or Pharmaceutical industry
- Strong knowledge of global regulatory requirements, including FDA, EMA, and other regional regulatory bodies
- Experience with product registrations and submissions in multiple countries
- Excellent written and verbal communication skills
- Strong attention to detail and organizational skills
- Ability to work independently and as part of a team
- Bachelor's degree in a relevant field, advanced degree preferred
- Fluency in English, additional languages a plus

**Benefits