Responsibilities:
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.
Private accident insurance.
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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