Global Regulatory Affairs Associate
vor 4 Wochen
Stratpharma AG, a rapidly expanding Dermatology company, is seeking a highly skilled Global Regulatory Affairs Associate to drive compliance and support global product registration.
This is an exciting opportunity to join a company with impressive 200% year-on-year growth and significant expansion plans. With 8 products on the market and 5 more in development, the successful candidate will play a crucial role in ensuring regulatory compliance and supporting the global registration process.
Key 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
What We Offer:
A competitive salary with high bonus (20%) and benefits, working in a dynamic and family-friendly environment with opportunities for growth and professional development.
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