Regulatory Affairs lead

Job Description

Our site in Groningen is part of the world class Pharma Services of Thermo Fisher Scientific. We are looking for an experienced Regulatory Affairs Lead for our complex and highly regulated environment.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, for example helping customers in finding cures for cancer, protecting the environment or making sure our food is safe! You will have a real-world impact, and you’ll be supported in achieving your career goals. Pharma Services offers our clients a powerful platform for their drug development with technologies that are industry standard to ultra-modern (including Single Use Technologies such as Single Use Bioreactors).

Discover Impactful Work

Take part to our entity's growth by enhancing our Regulatory Services Offering on clinical and commercial biological products and providing key deliverables to our Customers for domestic and international jurisdictions. Additionally, while benefiting from the site quality environment, there are opportunities to further explore and collaborate on regulatory compliance activities requiring local & foreign health authorities interactions.

The job

Regulatory Knowledge and Expertise

Stay abreast on procedural & CMC related regulations by monitoring relevant pharmaceutical regulations, leveraging from internal community of practices and leaning into specialized industry trade association working group. There are three major focus areas:

Regulatory Services

Promote and capture regulatory services as part of our integrated offering concept while partnering with Business. Draft quotations using the available tools in relation with the Quotes function.

Provide project regulatory liaison within multi-sites integrated offerings and to with Customer’s regulatory counterpart. Counsel on regulatory matters and define regulatory strategies per latest standards.

Author and review CMC / CTD M3 - Quality documents for clinical & commercial applications relevant to EU (IMPD-MAA-Variations), US (IND-BLA-PAS-CBE-AR) and RoW markets. Assist in deficiency letters/questions from regulatory agencies. Be accountable for yearly assigned regulatory revenue target, track invoices through revenue recognition in relation with Finance.

Regulatory compliance

Responsible for the maintenance of Customer's product registration information (CMC data base) and translation into production and quality control master documents. Perform a gap analysis between Customer’s product CMC information and operations practices within new product introduction and regulatory inspections' preparedness. Participate to Change Control process by defining regulatory requirements (ex: process, batch size, starting material supplier change ...)

Collaborate to components compliance and evolving regulations by partnering with Quality Control (ex/ Elemental Impurities, Nitrosamines..).Set-up and optimize vital regulatory systems and SOP in relation to these activities. Ensure adequate archiving of relevant documents.

Regulatory reporting

The Regulatory Affairs Leads drives with a passion the adherence to key deliverables' plan feeding into Global Regulatory Affairs reporting (data entry) including regulatory services metrics.

To be successful

• You have a Bachelor degree in Life Sciences (ex: Pharmacy, Chemistry, Microbiology).

• A minimum of 4 years of shown experience in working in a CMC regulatory role with biopharmaceutical industry (ideally with exposure to mammalian cell culture).

• Proficient on biologics CMC regulatory requirements for clinical and commercial bulk drug substances according to EMA, FDA, ICH primarily as well as having an understanding of the respective registration procedures.

• Adaptable to a dynamic work environment.

• Agile in interacting with management & leadership as well as Customers and other external partners.

• Customer-centric attitude with business sense.

• Ability to work with cross-functional teams as well as in a matrixed environment.

• Ability to prioritize workload to meet timelines.