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Director, Regulatory Affairs EU & APAC

Thermofisher Scientific
Swindon
5 days ago
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Overview

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 Contract Manufacturing & Development Organization (CDMO). This recognized leadership role adopts following core strategic activities:


Responsibilities

  • 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.
  • Advanced Degree or equivalent experience in European Life Science (e.g. Pharmacy, Chemistry, Microbiology).

Qualifications

  • 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. Understanding and application of ICH, EMA & FDA requirements, GMP & Quality guidelines.
  • Proven track record to mentor teams within a multicultural/multidisciplinary framework. Strong organizational skills with the ability to multi-task in a fast-paced environment and effective time management and prioritization skills.
  • Strong communication, negotiation and influencing skills with internal and external partners. Ability to demonstrate discretion, confidentiality and independent judgement. Effective verbal and written communication skills. Business sense. Proficiency in typical office electronic platforms and IT agility. Full proficiency in English; proficiency in another language is a complementary asset.
  • Ability to sustain travel schedule of approximately 25% essentially in EU.


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