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 alignment with corporate standards and customer requirements.
- Provide guidance and support to local RAC teams in developing CMC and regulatory strategies, ensuring consistency with corporate standards.
- Coordinate regulatory activities for corporate projects, ensuring timely and effective submission of regulatory documents.
- Chair the corporate RAC organization, ensuring effective communication and collaboration with cross-functional teams.
- Develop and maintain a harmonized RAC standard, ensuring consistency across all sites.
- Oversee the maintenance of e-CTD submission software, ensuring compliance with regulatory requirements.
Requirements:
- Ph.D. Chemist or Pharmacist or equivalent scientist with a strong background in RAC and CMC development.
- At least 5 years of experience in an RA department, with a strong understanding of GMP and e-CTD systems.
- Excellent leadership and communication skills, with the ability to work effectively in a team environment.
- Strong decision-making capabilities, with a service-oriented mentality.
- Good intercultural skills, with the ability to communicate effectively in English.
What We Offer:
- A dynamic work environment with high-quality infrastructure.
- Interesting opportunities 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.
- A 13th monthly salary is paid out without any social benefits deductions, in addition to a profit-sharing scheme 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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Senior Manager Corporate Regulatory Affairs Specialist
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Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS VollzeitJob DescriptionAbout 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...
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