Regulatory Affairs Manager

Specific Job Requirements

Expert on the regulatory environment and intelligence within the UK and Ireland and contributes to preparing new local regulatory guidance documents when applicable.

Managed initial marketing authorization (MA) applications, variations, and other MA maintenance applications.

Timely and compliant filing of clinical trial applications, amendments, and other clinical trial submissions.

Reviewer for promotional and non-promotional activities and materials and ensuring their compliance with the licence, local guidance, codes of conduct and Gilead SOPs

Establishes and maintains good and strong relationships with all functional areas of the local organisation (Medical Affairs, Commercial, Market Access, Legal, etc) and with Gilead Sciences Global RA to ensure the success of local and international business results from the regulatory point of view

Local GxP compliance expert assisting with and where appropriate leading the local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives

Initiates or contributes to local process improvement initiatives and subsequent procedural document development

Provide regulatory expertise for local business initiatives including market access, business compliance and medical-led  projects

Responsible for ensuring product packaging and associated information is updated and maintained by product SmPCs

Develop expertise in assigned Therapeutic Area, and become Subject Matter Expert (SME) for assigned core Regulatory activities

Knowledge, Experience & Skills

Requires a minimum of 5-10 years of experience in Regulatory Affairs, in an affiliate or global role

Science degree/Masters and relevant experience in Regulatory Affairs

Knowledge and awareness of UK/IE regulatory guidelines and legislation, with good working knowledge of the impact of Brexit

Highly experienced in filing national variations with MHRA, ideally with an interest or experience in eCTD, publishing, and the use of electronic portals

Experience in management of CTAs including amendments and other CT-related submissions

Experience in GxP compliance

Experience in review of promotional and non-promotional material per the UK and Irish industry codes of practice would be advantageous

Expert project management and time management

Excellent organisation skills and interpersonal skills

Excellent verbal and written communication skills in English

Is recognised as a knowledgeable resource within the department on a range of regulatory topics

Able to work equally well as part of a team or independently

Job Title: Regulatory Affairs Manager

Location: Hertfordshire, UK

Job Type: Contract

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.

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