Associate Director Regulatory Affairs Cmc
3 mesi fa
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
We are hiring an Associate Director Reg Affairs - CMC for one of our key clients.
This is a position to lead and execute CMC regulatory strategy and submissions for EMEA region. Its major function will be to lead the **CMC Regulatory Strategy and submissions for Biologicals**:
**Responsibilities**:
- Lead the development and execution of CMC regulatory strategies for biological products in the EMEA region.
- Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with internal teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies.
- Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAA and variations.
- Coordinate responses to CMC-related questions and deficiencies raised by the EMA or other EMEA health authorities during product registration.
**Post-Approval Compliance and Lifecycle Management**:
- Perform change control impact assessment for CMC changes
- Lead the CMC regulatory management and submission planning of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products
- Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
- Monitor and assess regulatory guidance related to biologics and provide strategic input into regulatory filings.
**SKILLS AND COMPETENCIES**:
- Strong knowledge of EMA regulations, ICH guidelines, and EMEA-specific CMC regulatory requirements for biologics.
- Proven experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management.
- Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements.
- Excellent project management skills with the ability to manage complex projects and timelines.
- Strong communication and interpersonal skills, with experience working in cross-functional and international teams.
- Fluent in English - working language.
**EDUCATION, EXPERIENCE AND QUALIFICATIONS**:
- Master degree or PhD in biotechnology, pharmaceutical sciences or bio‐engineering, with relevant expertise in CMC development and CMC regulatory for biological products (min 10 yrs)
**What we offer**:
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
LI-AS3
-
Regulatory Affairs Cmc
6 mesi fa
Milano, Italia HAYS A tempo pienoAzienda Farmaceutica - Affari Regolatori - Regulatory Affairs CMC - GMP La tua nuova aziendaIl nostro cliente è una realtà multinazionale che produce e commercializza prodotti farmaceutici generici.Il tuo nuovo ruoloIn ottica dell’ampliamento dell’organico, siamo alla ricerca di una figura di Regulatory Affairs CMC.La risorsa risponderà direttamente...
-
Associate Director Regulatory Affairs Cmc
6 giorni fa
Milano, Italia Thermo Fisher Scientific A tempo pieno**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Cmc Regulatory Affairs Manager
1 mese fa
Milano, Italia Fondazione Telethon ETS A tempo pienoFondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...
-
Associate Director, Regulatory Affairs
1 mese fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....
-
Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Italy (Milan) – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...
-
Associate Director, Regulatory Affairs
2 mesi fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology....
-
Cmc Regulatory Affairs Manager
1 mese fa
Milano, Italia Fondazione Telethon Ets A tempo pienoFondazione Telethon is one of Italy's leading non-profit organisations.Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases.For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure.We want to change this state of affairs because every person is important to...
-
Cmc Regulatory Affairs Manager
1 mese fa
Milano, Italia Fondazione Telethon Ets A tempo pienoFondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...
-
Associate Director, Regulatory Affairs
3 settimane fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology.Due...
-
Associate Director, Regulatory Affairs
1 mese fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
-
Associate Director, Regulatory Affairs
4 settimane fa
Milano, Italia Cpl Healthcare A tempo pienoJob Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance Job Type: Full Time, Permanent Position Location: Italy (Milan) – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
-
Principal Regulatory Affairs Consultant
3 mesi fa
Milano, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve.Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule.The ideal candidate will possess strong regulatory affairs...
-
Director, Regulatory Affairs
5 mesi fa
Milano, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve.We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team.As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction.You will provide mentorship, leadership and direction to Managers and consulting...
-
Regional Director, Regulatory Affairs
1 mese fa
Milano, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve.We are seeking a highly skilled and experienced Regional Regulatory Affairs Director (EMEA) to join our team.As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction.You will provide mentorship, leadership and direction to Managers...
-
Regional Director, Regulatory Affairs
3 settimane fa
Milano, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve.We are seeking a highly skilled and experienced Regional Regulatory Affairs Director (EMEA) to join our team.As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction.You will provide mentorship, leadership and direction to Managers...
-
Senior Regulatory Affairs Manager
3 settimane fa
Milano, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager / Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a...
-
Senior Regulatory Affairs Manager
3 mesi fa
Milano, Italia Parexel A tempo pienoWhen our values align, there's no limit to what we can achieve.We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise.This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global...
-
Regional Director, Regulatory Affairs
3 settimane fa
Milano, Italia Buscojobs A tempo pienoWhen our values align, there's no limit to what we can achieve.We are seeking a highly skilled and experienced Regulatory Affairs Director to join our team.As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction.You will provide mentorship, leadership and direction to Managers and consulting...
-
Contractor Regulatory Operations Associate
1 settimana fa
Milano, Italia Adh Personal Thüringen A tempo pienoRandstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate. The candidate will be in charge of regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed...
-
Contractor Regulatory Operations Associate
6 giorni fa
Milano, Italia Adh Personal Thüringen A tempo pienoRandstad Inhouse Services, specialty Pharma, is looking for a resource on behalf of Pfizer srl to join the regulatory team as Contractor Regulatory Operations Associate. The candidate will be in charge of regulatory change management, renewal, and query activities for products manufactured by External Supply Quality (ESQ) managed contractors....
