Senior Manager Corporate Regulatory Affairs Specialist
vor 2 Monaten
About the Role:
We are seeking a highly experienced and skilled Senior Manager Corporate Regulatory Affairs to join our team at CARBOGEN AMCIS. As a key member of our Corporate Quality Organization, you will be responsible for leading our Regulatory Affairs department and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Develop and implement regulatory strategies for new development projects, ensuring compliance with corporate standards and customer requirements.
- Provide guidance and support to operators on the issuance, submission, and maintenance of regulatory documents, including DMFs, CMC documentations, and e-CTD submissions.
- Coordinate regulatory activities across CARBOGEN AMCIS RAC groups and consult with project teams on regulatory questions.
- Chair the corporate RAC organization and maintain the e-CTD submission software.
- Develop and maintain a harmonized RAC standard and take ownership of the RAC chapter in the Corporate Management Handbook.
Requirements:
- Ph.D. Chemist or Pharmacist or equivalent scientist with at least 5 years of experience in an RA department.
- Excellent knowledge of RAC and CMC development, GMP, and e-CTD systems.
- Strong leadership and decision-making skills, with experience in dealing with authorities and customers.
- Good intercultural skills, communication style, and English language skills.
- Flexible working attitude and team-oriented leadership skills.
What We Offer:
- 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.
- 13th monthly salary and profit sharing in a successful business year.
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Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS VollzeitJob Title: Senior Manager Corporate Regulatory AffairsAbout the Role:We are seeking a highly experienced Senior Manager Corporate Regulatory Affairs to join our team at CARBOGEN AMCIS. As a key member of our Corporate Quality Organization, you will be responsible for leading our Regulatory Affairs function and ensuring compliance with regulatory...
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