Director, Regulatory Affairs Eu & Apac
Pubblicato il 31-07-2026 - Thermo Fisher Scientific in Milano
**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Discover Impactful Work**:
Join Thermo Fisher Scientific Inc and more specifically our Pharmaceutical Service Group (PSG) as Director, EU/APAC Regulatory Affairs ! Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within our Contrat Manufacturing & Development Organization (CDMO). This recognized leadership role adopts following core strategic activities: - ** Mentoring a community of above site and site-based individuals while supplying to their progress**: - ** Encouraging EU & APAC regulations knowledge within the Global Q/RA network,**: - ** Engaging in Global Q/RA initiatives,**: - ** Improving site & product compliance to the latest regulatory standards,**: - ** Promoting regulatory services, ensuring associated deliverables and revenue to support our business growth trajectory.**: - ** Interacting with key Customers & Regulatory Agencies to develop and implement regulatory strategies while ensuring successful experience & high reputation.**:
**Keys to Success**:
**Education**:
Advanced Degree or equivalent experience in European Life Science (e.g. Pharmacy, Chemistry, Microbiology). **Experience**:
Minimum **15** years of relevant **pharmaceutical regulatory affairs** in the **drug product** space (including CMC technical dossiers writing) with cGMP manufacturing operational exposure in **sterile**environment. Previous CDMO experience is a competitive advantage. **Proficiencies**:
Intimate knowledge of EU regulatory landscape (including GMP essentials) and exposure to professional communities such as **TOPRA, PDA**. 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 and effective time management and prioritization skills. 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. Ability to demonstrate discretion, confidentiality and independent judgement. Effective verbal and written communication skills. Business sense. Sound skills in typical office electronic platforms and IT agility. Full proficiency in English, proficient in another language is a complementary asset. Ability to sustain travel schedule of approximately **25%** essentially in EU.