Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Regulatory Affairs Manager

Swindon, UK/Full time

Work Schedule

Standard (Mon-Fri)

Job Description

Responsibilities:

Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies!

Perform regulatory surveillanceAssess 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 scienceA 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 requirementsDynamic, self-motivated, pro-active approach to taking on challenging assignments.Strong communication and collaboration skillsAbility 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.