Senior Manager, EU & APAC Regulatory Affairs
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇳🇱 Netherlands
Visit company websiteJob Level
Senior
About the role
- Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within CDMO
- Mentor a community of site-based individuals
- Engage in Global Q/RA initiatives and improve site & product compliance
- Interact with key Customers & Regulatory Agencies to develop and implement regulatory strategies
- Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations impacting our large molecule Drug Substance business
- Collaborate in PSG Quality transformation initiative through compliance and QMS inputs
- Enhance regulatory services offering and associated revenue generation
- Define DSD large molecule yearly objectives and ensure timely delivery
Requirements
- Advanced Degree or equivalent experience in European Life Science (e.g. Pharmacy, Chemistry, Microbiology)
- Minimum 12 years of relevant pharmaceutical regulatory affairs in the drug substance large molecule space (including CMC technical dossiers writing)
- Intimate knowledge of EU regulatory landscape (including GMP essentials)
- Understanding and application of ICH, EMA & FDA requirements, GMP & Quality guidelines
- Significant and proven track record to successfully mentor performing teams within a multicultural/multidisciplinary framework
- Sophisticated organizational skills, with ability to multi-task in a fast-paced environment
- Strong social skills who champions open communication and facilitates mutual understanding and collaboration between all partners.
- Negotiation and influencing skills with relevant partners, internally-externally.
- Full proficiency in English, proficient in another language is a complementary asset.
- Ability to sustain travel schedule of approximately 25% essentially in EU
Benefits
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
pharmaceutical regulatory affairsCMC technical dossiers writingEU regulatory landscapeGMP essentialsICH requirementsEMA requirementsFDA requirementsQuality guidelinesregulatory strategiesregulatory compliance
Soft skills
mentoringorganizational skillsmulti-taskingopen communicationcollaborationnegotiation skillsinfluencing skillssocial skillsteam leadershipcultural awareness
Certifications
Advanced Degree in Life Science