Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Regulatory Affairs Manager
Swindon, UK | Full time
Responsibilities:
* Perform regulatory surveillance
* Assess regulatory feasibility of new requests and address local impact
* Establish a centre of expertise shared within the Thermo Fisher network
* Participate in external working groups within professional bodies
* Maintain official authorisations and master documentation in collaboration with regulatory agencies
* Ensure inspection and audit readiness
* Archive official documents
* Maintain regulatory databases and ensure data integration into production and quality documents
* Participate in Change Control processes by defining regulatory requirements
* Manage regulatory quotations and invoice follow-up
* Identify regulatory business opportunities
* Provide regulatory guidance and strategy
* Coordinate and review CMC/Quality documentation
* Supervise client registration lifecycle activities
Requirements:
To succeed, candidates should have experience in regulatory affairs within the legal framework, including:
* B.Sc. or equivalent in Pharmacy, Chemistry, Microbiology, or related sciences
* At least 7 years of practical regulatory affairs experience, including filing activities and site compliance
* Knowledge of UK, European, US, and international pharmaceutical regulations, including GMPs and UK Ministry of Health operations
* Deep understanding of regulatory strategy, design control, cGMP, quality systems, and import/export requirements
* Proactive, self-motivated, and capable of handling challenging tasks
* Strong communication and collaboration skills
* Ability to meet critical deadlines
* Excellent written and oral communication skills with confidence to advocate proposals
We offer flexible benefits, including pension and healthcare, along with competitive salaries.
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