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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Regulatory Affairs Manager
Swindon, UK/Full time
Work Schedule
Standard (Mon-Fri)
Responsibilities:
Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies!
- Perform regulatory surveillance
- Assess regulatory feasibility of any new request (primary focal point) and address local impact.
- Establish centre of expertise to be shared within Thermo Fisher network.
- Externally, participate to working groups within professional bodies.
- Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP – MS – ISO – GMP certificate) and establishment master documentations (SMF – DMF – device technical file) collaborating with appropriate regulatory agencies.
- Ensure inspections & key audits readiness and/or participate.
- Responsible for archiving official documents.
- Supervise the maintenance of regulatory data bases (Client product registration information, components).
- Ensure integration of registration information into Production and Quality master documents (process and QC specifications).
- Participate to the Change Control process by defining regulatory requirements.
- Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators.
- Identify areas of regulatory business opportunities (PDS and others).
- Provide regulatory guidance (strategy definition, requirements assessment).
- Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review.
- Supervise Client registration life-cycle activities (renewals, MoH questions).
Requirements:
To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have:
- B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science
- A minimum of 7 years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities.
- UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health.
- Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements
- Dynamic, self-motivated, pro-active approach to taking on challenging assignments.
- Strong communication and collaboration skills
- Ability to work with critical timelines.
- Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.
We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.
