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Manager, CMC Regulatory Affairs
2 settimane fa
Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group's main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.
As part of the Regulatory Affairs team, the Manager, CMC Regulatory Affairs, leads the development of CMC regulatory strategies and prepares the filing documentation (Module 3 or equivalent) to support the registration and lifecycle management of Bracco's contrast agent products in the U.S. market.
Key Responsibilities
- Provide strategic leadership and expert guidance on CMC regulatory matters to register and maintain Bracco drug substances and drug products in the U.S.
- Ensure compliance with CMC regulatory requirements and guidelines (ICH, US FDA CFRs, Guidances, and available FDA review documents).
- Develop and author high-quality CMC (Quality) documentation, specifically Module 2.3 and Module 3, for regulatory submissions to the FDA, including INDs, NDAs, BLAs as well as post-approval supplements and annual reports.
- Contribute to outline the CMC strategy for meetings with the FDA.
- Identify potential CMC regulatory risks and support mitigation strategies.
- Regulatory expert for assigned teams, responsible for the U.S. CMC.
- Provide regulatory impact of CMC change controls for the U.S. registrations and ensure the necessary variations to the DMFs and NDAs/INDs are submitted for review and/or approval (amendments/PAS/CBE/Annual Reports).
- Collaborate with Quality Management Unit, Corporate and local functions, to support quality compliance.
- Manage CMC regulatory documentation efficiently; experience with Veeva RIM is an advantage.
Monitors FDA environment for changes/updates in CMC requirements and provide feedback to appropriate Bracco functions.
Education & Experience
- Master's degree (PhD or equivalent preferred) in Chemistry, Pharmacy (CTF), Chemical Engineering, or related field.
- Minimum 10 years of Regulatory Affairs experience, with strong focus on CMC in the pharmaceutical or biotechnology industry.
- Solid knowledge and proven experience of CMC regulatory requirements for FDA.
- Required understanding of chemical (organic synthesis of drug substances) and pharmaceutical (sterile injectables products) manufacturing processes.
- Ability to work both independently and collaboratively, demonstrating leadership in managing regulatory activities and making strategic decisions throughout the product lifecycle.
- Previous experience with radiopharmaceuticals or contrast agents is a plus.
- Excellent technical writing and verbal communication skills.
- Strong project management abilities, with proven experience managing multiple projects in a fast-paced environment.
Key Interfaces
- Technical Operations, including manufacturing sites
- Corporate and Local Quality Management & Quality Assurance
- Research & Development
- Medical Affairs
- Contract manufacturers
If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now
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