Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Director, EU & APAC Regulatory Affairs

Location/Division Specific Information:

Location: Europe hybrid (contractually linked to a PSG site)

Specificity: DSD Large Molecule centricity

Reporting: Sr. Director, EU & APAC Regulatory Affairs

Discover Impactful Work:

Join Thermo Fisher Scientific Inc., 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 leadership role embraces 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.

1. 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 organization.

· Improve internal regulatory knowledge by developing appropriate forums & tangible trainings.

1. 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.

1. Regulatory Services

Enhance regulatory services offering and associated revenue generation:

· Monitor Accelerator / Integrated Offering programs interfaces between PSG (DSD large molecule and DPD sterile EU & APAC sites) and CRG entities as applicable

· Facilitate Path to IND programs execution

· 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.

1. 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., Biology, Chemistry, Pharmacy, Microbiology).

Experience:

Minimum 15 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.