* 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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