Head Of Corporate Regulatory Affairs & Cmc

• Support the elaboration, establishment, and application of the RA standard at all sites.
• Ensure internal standards for regulatory compliance of regulated products, considering customer requirements.
• Consult with local RAC teams on developing CMC and regulatory strategies for new projects, ensuring adherence to corporate RAC standards.
• Guide operators in issuing, submitting, and maintaining regulatory documents (DMFs, CMC documentation for INDs, IMPDs, NDAs, MAAs, etc.).
• Support the implementation and application of corporate standards at respective sites.
• Coordinate regulatory activities across CARBOGEN AMCIS RAC groups during CMC process development and advise project teams on regulatory matters.
• Chair the corporate RAC organization within the Corporate Quality Organization.
• Own the RAC chapter in the Corporate Management Handbook, defining and maintaining a harmonized RAC standard.
• Maintain e-CTD submission software.

Requirements :

• Ph.D. in Chemistry, Pharmacy, or an equivalent scientific field.
• Strong knowledge of RAC (drug substances and / or drug products) and CMC development.
• Good GMP knowledge.
• Familiarity with e-CTD systems.
• Minimum 5 years of experience in an RA department (Drug Substances or Drug Products).
• At least 5 years of work or management experience in an RA / GMP environment.
• At least 5 years of experience dealing with authorities and customers.
• Leadership or consultancy experience of at least 5 years.
• Good intercultural skills and communication style.
• Proficiency in English, both oral and written.
• Flexible attitude and willingness to work overtime.
• Team-oriented leadership skills with strong decision-making abilities.
• Service-oriented mentality.

Benefits :

• Dynamic work environment with high-quality infrastructure.
• Opportunities to develop professional skills.
• Flexible working hours for a 40-hour week.
• Minimum of 5 weeks vacation.
• Travel insurance for private travel.
• 13th salary paid without social benefits deductions, plus profit sharing in successful years.

For further information, please contact the Human Resources department.

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