Lavori attuali relativi a Manager, CMC Regulatory Affairs – U.S. Market - Milano, Lombardia - Bracco Imaging
-
Associate Director, Regulatory CMC
1 settimana fa
Milano, Lombardia, Italia Singular: Building Brilliant Biotechs A tempo pieno 60.000 € - 120.000 € all'anoAssociate Director – Regulatory CMCAre you a CMC regulatory expert with experience across product development, submissions, and lifecycle management? This is an opportunity to lead global CMC regulatory strategy for a biopharma organisation advancing innovative therapies across multiple modalities.THE COMPANYThis pioneering biopharmaceutical company is...
-
Regulatory Affairs Manager
3 giorni fa
Milano, Lombardia, Italia Bayer A tempo pieno 70.000 € - 90.000 € all'anoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Regulatory Affairs Manager
3 giorni fa
Milano, Lombardia, Italia Bayer A tempo pieno 60.000 € - 120.000 € all'anoAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Regulatory affairs manager
3 giorni fa
Milano, Lombardia, Italia The Human Factor A tempo pieno 55.000 € - 110.000 € all'anoPer azienda cliente, realtà attiva nello sviluppo e nella produzione di farmaci, dispositivi medici, cosmetici e integratori, con un forte orientamento alla qualità e all'innovazione, siamo alla ricerca di un/una:Regulatory Affairs ManagerLa figura avrà un ruolo centrale nel garantire la conformità normativa dei prodotti lungo tutto il loro ciclo di...
-
Junior Regulatory Affairs Specialist
17 ore fa
Milano, Lombardia, Italia Amway A tempo pieno 30.000 € - 60.000 € all'anoJob DescriptionApply nowJob Title: Junior Regulatory Affairs SpecialistPosting Start Date: 12/5/25Posting Location: Milano, ITRequisition ID: 42652Amwayis the world's #1 direct selling company and one of the largest family-owned businesses globally. Since 1959, we've been empowering people with innovative solutions and over 450 premium products in nutrition,...
-
Regulatory Affairs Officer
18 ore fa
Milano, Lombardia, Italia ProductLife Group A tempo pieno 40.000 € - 60.000 € all'anoPharma D&S, società del gruppo PLG, è una società di consulenza nel settore Farmaceutico e Lifesciences in grado di fornire servizi tempestivi, efficienti e di elevata qualità nell'ambito di: Quality & Process, Regulatory Affairs, Farmacovigilanza e Studi Clinici.Cerchiamo un/aRegulatory Affairs Officerda inserire nel team di Cassina de' Pecchi (MI) o...
-
Market Access Manager – Italy
3 giorni fa
Milano, Lombardia, Italia Pharma Point A tempo pieno 50.000 € - 80.000 € all'anoMARKET ACCESS MANAGER – ITALYPharma Point is seeking a Market Access Manager on behalf of a leading multinational pharmaceutical company operating in the field of rare diseases. The role will be based in Milan and will play a strategic part in ensuring timely and sustainable access of the company's therapies to patients across Italy.As part of the national...
-
Stage Regulatory Affairs
1 settimana fa
Milano, Lombardia, Italia d64b56fb-9b57-41ad-8e36-14d65cec3c93 A tempo pieno 30.000 € - 45.000 € all'anoOpella is the self-care challenger with the purest andthird-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands bymaking self-care as simple as it should befor over half a billion consumers worldwide.At the core of this mission is our100+ loved brands,...
-
Stage Regulatory Affairs
1 settimana fa
Milano, Lombardia, Italia d64b56fb-9b57-41ad-8e36-14d65cec3c93 A tempo pieno 30.000 € - 40.000 € all'anoOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.At the core of this mission is our 100+ loved brands ,...
-
Stage Regulatory Affairs
1 settimana fa
Milano, Lombardia, Italia Opella A tempo pieno 2.000 € - 2.500 € all'anoOpella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission: to bring health in people's hands by making self-care as simple as it should be for over half a billion consumers worldwide.At the core of this mission is our 100+ loved brands, our...
Manager, CMC Regulatory Affairs – U.S. Market
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
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
