Function: CMC/Regulatory Project Manager
Hierarchy: reports to the CDO
- In collaboration with the CMC manager, management of process development activities and GMP pharmaceutical operations
- Manage and coordinate the activities and budget with the external CMOs/vendors
- Participate to the review and approval of master batch records, executed batch records, manufacturing deviations and investigations
- Manage external CMOs for the development of appropriate methods for release testing and for stability indicating properties.
- Participate with external QA to on-site audits as needed.
- Review and approve study protocols/reports and documentation for compliance with cGMP and other appropriate regulations and guidelines
- Responsible for various regulatory contributions: writing and/or review of the quality IMPD/CMC IND sections and responses to the authorities.
- Interface with global Project Management to ensure timely completion and as needed with other disciplines as needed (e.g., Clinical, Nonclinical)
Diploma’s / Degrees: Master in regulatory / PhD / PharmD
- Scientist (MSc/PhD) or pharmacist with a minimum of 10 years’ experience within CMC/quality- regulatory functions
- Experience with peptides or proteins-based products needed
- Experience or close interactions with analytical development /QC activities would be a plus
Languages: French, English
Informatics : basic knowledge
- Proven project management skills
- Ability to embrace ambiguity and complexity and demonstrate problem-solving leadership with limited oversight
- Strong organizational skills and attention to detail