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Senior Manager, EU & APAC Regulatory Affairs

Thermo Fisher Scientific

Closing date
31 January 2026 12:00am

Join Thermo Fisher Scientific Inc., more specifically our Pharmaceutical Service Group (PSG) as Sr. Manager, EU/APAC Regulatory Affairs !

Support regional matrix expansion to strengthen Regulatory Compliance & Regulatory Services for Drug Substances & Drug Products within our Contrat Manufacturing & Development Organisation (CDMO).

This leadership role embraces the following core strategic activities:

  • Mentoring a community of site-based individuals while contributing to their progress,
  • Encouraging EU & APAC regulations knowledge applicable to large molecule 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.

A day in the Life:

1. Regulatory management
Within assigned business units (BIO, mRNA, VVS), matrix manages our EU & APAC DSD large molecule network (5 sites, 5 people):

-Partner with site line managers on regulatory talents strategies and engage in staff recruitment, on-boarding, development, career journey/succession.

-Collaborate to HR calendar turning points such as goals setting, calibration and performance reviews.

2. Regulatory intelligence

-Monitor, anticipate, pre-evaluate and communicate on major pharmaceutical regulations impacting our large molecule Drug Substance business:

-Lean in reputable industry association, influence on trends and provide SME consultation to the organisation.

-Improve internal regulatory knowledge by developing appropriate forums and tangible training.

3. Regulatory compliance

-Collaborate in PSG Quality transformation initiative through compliance and QMS inputs (Global Policy, Procedures, Job Aids, Positions Papers crafting) and implementation facilitation.

-Elevate regulatory systems to the next level by supporting automation, digital transformation, simplification & harmonization and participate in programs within our function.

-Perform site regulatory compliance duties: oversee domestic licenses, foreign accreditations, master documents (SMF/DMF) conformity for matrixed sites and support major regulatory inspections’ preparedness jointly with Qualified/Responsible Persons.

-Perform product regulatory compliance duties: leverage regulatory systems use and engage in critical quality issue resolution within matrixed sites while partnering with Qualified Person/Site Quality Head.

4. Regulatory services

-Enhance regulatory services offering and associated revenue generation:

-Identify & develop areas of growth upon creative business models setting/revisit;

-Influence key EU & APAC projects within new product introduction/technology transfers or new strategic Customers;

-Lead major regulatory quotations’ issuance;

-Deliver ad hoc expertise on registration files relevant to new applications (IMPD-MAA/ IND-NDA-BLA) and post-approval changes (variations/PAS-CBE30-AR) and assess overall regulatory acceptance/risk.

5. Regulatory reporting

In charge of defining DSD large molecule yearly objectives, making sure that input from various sites is delivered on time and performance remains relevant.

 

Keys to success:

Education:

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

Experience:

  • Minimum 12 years of relevant pharmaceutical regulatory affairs in the drug substance large molecule space (including CMC technical dossiers writing) with cGMP manufacturing operational exposure in biological 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 CASSS, TOPRA.
  • 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 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.
  • Responsible for reporting key indicators for matrixed sites on a quarterly basis.

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