Senior Regulatory Specialist job in London, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Consultant / Specialist

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting a Senior Regulatory Specialist in London, this is also a remote opportunity. You will be expected to execute regulatory strategies for an established pharmaceutical organisation in the UK. You will oversee MHRA affairs across the organisation.

Job Responsibilities

Prepare and submit high quality regulatory filings for the UK affiliate to the MHRA.
Support and action the regulatory end-to-end process to execute company and Brexit related activities.
Maintain marketing authorisations (MAs) approved via National, Mutual Recognition/Decentralised and Centralised procedures.
Generate and maintain prescribing information, patient information leaflets and packaging components, including artwork implementation and management
Provide regulatory input to business stakeholders on potential product issues and deletions/divestitures for the respective product portfolio.
Implement and communicate changes to relevant stakeholders, and ensure all compliance activities and company systems are correctly managed.
Work as an effective member of the UK regulatory team, contributing with strong experience and understanding of the evolving UK regulatory framework.
Able to work to stimulating deadlines and manage conflicting priorities with sound time-management skills.

Skills and Requirements

BSc. Degree or higher (or equivalent qualifications/experience) in pharmacy or a life-science subject.
5+ years of working in a regulatory affairs role in the pharmaceutical industry is necessary with in-depth knowledge of EU/UK regulatory procedures and a comprehension of EU and UK Medicines Legislation.
Experience of working in UK affiliate regulatory role, with preparation and submission of applications to and working with the MHRA.
Able to work on own initiative and take be accountable for managing the day-to-day regulatory activities for a portfolio of products.
Experience of working within electronic regulatory tracking databases and document/artwork management systems.

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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