**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.
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