Cmc Regulatory Affairs Manager
Vor 3 Tagen
CMC Regulatory Affairs Manager
For our client we are looking for an exeprienced CMC Regulatory Affairs Manager who provide expert content guidance for quality portions of the CTD, ensuring compliance of documentation to internal company standards and external regulatory guidelines.
**Responsibilities**:
- Maintenance of registration files
- Manage post-marketing regulatory activities of chemical pharmaceutical drug products
- Coordinate with partners’ regional regulatory teams for global strategy
- Define, develop and lead regulatory strategies for post-marketing and clinical development activities
- Maintenance and update of the Product Information
- Prepare and review regulatory submissions
- Manage CMC activities
- Internal Regulatory contact for Pharmacovigilance, Marketing and Business
- Maintain policy and regulatory intelligence
- Provide regulatory strategies
**Required experience**:
- Degree in Science
- 5 years of experience in pharmaceutical regulatory affairs for sterile parenteral chemical drugs
- Experience in regulatory activities for Chemical Pharmaceutical Drug Products (phase I-III)
- Knowledge of ICH Quality Standards, European and US pharmacopoeias, International CMC Guidances, including ASEAN
- Experience in collaboration with health agencies
- Fluent French and English
- Very good attention to details and organizational skills
- Excellent written and oral communication skills
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