Regulatory Affairs Manager

vor 24 Stunden

Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

We are seeking a highly experienced Regulatory Affairs Manager to join our team at CARBOGEN AMCIS. In this role, you will be responsible for developing and implementing the company's regulatory affairs strategy, ensuring compliance with all relevant regulations and guidelines.

About the Role

This is a dynamic opportunity for an experienced RA professional who can take ownership of the CMC process development for corporate projects. You will work closely with internal and external stakeholders to ensure that all regulatory activities are coordinated effectively.

The ideal candidate will have a strong background in RAC and CMC development, with excellent knowledge of GMP and e-CTD systems. A Ph.D. in Chemist or Pharmacist or equivalent scientist is required, along with at least 5 years of experience in an RA department and leadership/consultancy roles.

Responsibilities
  • Develop and implement the company's regulatory affairs strategy, ensuring compliance with all relevant regulations and guidelines.
  • Coordinate the CMC process development for corporate projects, working closely with internal and external stakeholders.
  • Ensure that all regulatory activities are conducted in accordance with GMP and e-CTD systems.
  • Provide hands-on support in the implementation and application of the corporate standard at respective sites.
  • Chair the corporate RAC organization as part of the Corporate Quality Organization.
Requirements
  • Ph.D. Chemist or Pharmacist or equivalent scientist
  • Very good knowledge in RAC (drug substances and / or drug product) and CMC development
  • Good GMP knowledge
  • Familiar with e-CTD systems
  • At least 5 years experience in an RA department (Drug Substances or Drug Products)
  • At least 5 years work or management experience in an RA / GMP environment
  • Excellent communication style
  • Good English language skills, orally and in writing
Benefits
  • A competitive salary of approximately $140,000 per year, including a bonus structure
  • A dynamic work environment with high-quality infrastructure
  • Interesting possibilities to develop your professional skills
  • Flexible working hours for a 40-hour week
  • At least 5 weeks of vacation
  • Participation in childcare costs
  • Travel insurance for private travels
  • Private insurance in the event of an accident

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