Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Discover Impactful Work:
You will join a newly-established mRNA GMP manufacturing facility in Monza and will take part to the site overall conformance by advising on licensing strategies applicable to the innovative mRNA suite while partnering with the Qualified Person and realizing regulatory compliance activities per domestic & foreign requirements while interacting with relevant health authorities.
You will be instrumental in supporting the mRNA business entity's growth by being the Regulatory and Compliance point of contact for new projects while liaising with Customer’s technical/regulatory counterparts, promoting our services offering and facilitating regulatory related activities.
A day in the Life:
Regulatory Knowledge & Expertise
Advance knowledge on Italian laws and regulatory environment by leaning into specialized industry trade association working groups, digest and disseminate information, assist in impact assessment and implementation.
Stay abreast on ATMPs/mRNA regulatory ecosystem in major jurisdictions (EU, USA, ICH) by monitoring relevant pharmaceutical legislation and guidance and leveraging from internal community of practices.
Regulatory compliance
From a site perspective:
Lead the strategy definition for the establishment license extension to meet Customer needs, frame and submit corresponding facility data packages to regulatory agencies (primarily AIFA)
Provide regulatory assessment and guidance on new product introduction
Responsible for the issuance, maintenance and archiving of all domestic and foreign authorizations (AIFA manufacturing/import license & GMP certificate, FDA e-establishment registration, JP accreditation, etc.)
Supervise the life-cycling of Site/Drug Master Files and ensure relevant submissions
Support regulatory inspections and related preparedness activities
Establish and maintain relevant processes/SOPs and systems/database
Collaborate in change management related to site regulatory compliance duties
From a product perspective:
Responsible for the setting and maintenance of Customer's product registration information (CMC data base)Accountable for the translation of product registration information into production and quality control master documents through key materials review (e.g. drug substance/bulk drug substance specifications, batch records …)
Collaborate to components compliance and evolving regulations by partnering with Quality Control (e.g. TSE, elemental impurities, nitrosamines ...)
Participate to change control process by defining regulatory requirements (e.g. process, batch size, starting material supplier change ...)
Set-up and optimize necessary regulatory systems and SOP in relation to these activities
Ensure adequate archiving of relevant documents
Project Regulatory Liaison
Be the site regulatory liaison face to the Customer, follow-up on project regulatory submission plan (primarily clinical)
Draft quotations, deliver regulatory services parcels in relation to the site and supporting a Customer application (e.g. SMF, DMF, foreign accreditation, facility registration questionnaire …) and track invoices
Promote CMC regulatory services as part of our integrated offering concept by connecting and mutualizing capacities through Global Regulatory ATX SME
Regulatory reporting
Responsible for ensuring adherence to key deliverables' regional plan fostering into Global Regulatory Affairs reporting
Keys to Success:
Education
Bachelor degree in Life Sciences (e.g. Pharmacy, Chemistry, Microbiology ...)
Experience
Minimum 7 years working in a regulatory role with biopharmaceutical industry (ideally with exposure to ATMPs)
Knowledge, Skills, Abilities
Well-versed on site licensing requirements for clinical and commercial bulk manufacturing according to AIFA, EMA and FDA primarily as well as having an understanding of the respective procedures
General knowledge of phase-appropriate biologics CMC regulatory requirements for clinical and commercial bulk manufacturing in a GMP environment
Adaptable to a dynamic work environment
Agile in interacting with management & leadership as well as Customers and other external partners
Customer-centric attitude with strong business acument
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
Rigorous and attention-to-detail skills, especially in the completion and review of regulatory documentations
Ability to advise on regulatory solutions and influence partners
Sound skills in typically office electronic platforms and IT solutions
Physical Requirements / Work Environment
Adhere to OHS policies and procedures and ensure safe and healthy workplace environment.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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