Regulatory Affairs Manager

Thermo Fisher Scientific; Swindon; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading organization in the pharmaceutical sector seeks a Regulatory Affairs Manager based in Swindon, UK. The role involves overseeing regulatory strategies, maintaining compliance with authorizations, and ensuring readiness for inspections and audits. Candidates should have significant experience in regulatory affairs, with a strong background in UK and international regulations. The company offers competitive salaries along with flexible benefits including healthcare and pension.

Benefits

Pension

Healthcare

Qualifications

• Experience in regulatory affairs with hands-on practical experience.
• Knowledge of UK, European, US, and International pharmaceutical regulations.
• Strong communication skills, both written and verbal.

Responsibilities

• Perform regulatory surveillance and assess feasibility of new requests.
• Supervise maintenance of official authorisations and documentations.
• Ensure inspections and audits readiness.

Skills

Regulatory Surveillance

Communication

Collaboration

Self-motivation

Project Management

Education

B.Sc. in Pharmacy, Chemistry, Microbiology, or related science

Job description

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 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.