Manager, CMC Regulatory Affairs - U.S. Market

Bracco Group; Milano; Ibrido; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading healthcare organization in Milan is seeking a Manager for CMC Regulatory Affairs to lead the development of regulatory strategies for the U.S. market. The ideal candidate will have over 10 years of experience in Regulatory Affairs, particularly in CMC. Responsibilities include ensuring compliance with FDA regulations, leading documentation efforts, and collaborating with various departments. The position offers a hybrid work model and the chance to positively impact patient lives.

Competenze

• 10+ years of Regulatory Affairs experience focused on CMC.
• Solid knowledge of FDA CMC regulatory requirements.
• Ability to manage multiple projects in a fast-paced environment.

Mansioni

• Lead CMC regulatory strategies for U.S. market.
• Ensure compliance with FDA CMC regulations.
• Develop high-quality CMC documentation for regulatory submissions.

Conoscenze

Regulatory Affairs expertise

Technical writing

Project management

Collaboration

Formazione

Master's in Chemistry, Pharmacy or related

Strumenti

Veeva RIM

Descrizione del lavoro

Manager, CMC Regulatory Affairs - U.S. Market page is loaded## Manager, CMC Regulatory Affairs - U.S. Marketremote type: Hybridlocations: ITA - Milano - Via Egidio Follitime type: Full timeposted on: Posted Yesterdayjob requisition idBracco 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 manufacturersIf you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!At Bracco, we believe in the values of diversity and inclusion. We respect and celebrate the diversity of our people and their experiences, ensuring a fair opportunity for all.***We are #Bracco #JoinUs***remote type: Hybridlocations: ITA - Milano - Via Egidio Follitime type: Full timeposted on: Posted 30+ Days AgoImprove people’s lives by shaping the future of prevention and precision imaging. This is our purpose.Our work impacts millions of people all over the world. Not least the more than 4,000 Bracco colleagues who work to improve lives every single day. That is quite a responsibility and something we proudly embrace.***We are the Bracco Group!***