Regulatory Affairs lead

Job Description

Discover Impactful Work:

Take part to our entity's growth by enhancing our Regulatory Services Offering on clinical and commercial biological products and providing state of the art deliverables to our Customers for domestic and international jurisdictions.

Additionally, while benefiting from the site quality environment, opportunities to further explore and collaborate on regulatory compliance activities requiring local & foreign health authorities interactions will be available.

A day in the Life:

Regulatory Knowledge & 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.

Regulatory Services

Promote and capture regulatory services as part of our integrated offering concept while partnering with Business.

Draft quotations per available tools in relation with 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 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 necessary regulatory systems and SOP in relation to these activities

Ensure adequate archiving of relevant documents.

Regulatory reporting

Responsible for ensuring adherence to key deliverables' plan feeding into Global Regulatory Affairs reporting (data entry) including regulatory services metrics.

Keys to Success:

Education

Bachelor degree in Life Sciences (ex: Pharmacy, Chemistry, Microbiology ...)

Experience

Minimum 4 years working in a CMC regulatory role with biopharmaceutical industry (ideally with exposure to mammalian cell culture)

Knowledge, Skills, Abilities

Well-versed 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.

Effective verbal and written communication skills