Regulatory Affairs Manger.

Greater London/ contract / £350 per Day

I am currently recruiting for a Regulatory Affairs Manger to join a research-based biopharmaceutical company on a 12 month contract.
Based in High Holborn (3 days in office/2 days WFH)

An affiliate Regulatory Affairs role, the Manager / Senior Manager will assist in the local coordination and execution of regulatory submissions in compliance with corporate standards and national regulatory requirements, and of Regulatory Affairs processes and deliverables for the UK and Ireland.

The core elements of this pivotal role will include supporting local execution of the EU regional regulatory strategy, including clinical trial application (CTA) submissions and of the UK and Ireland affiliate commercial strategy, with a focus on Oncology and Acute Anti-infections.

Job Requirements
Expert on regulatory environment and intelligence within the UK and Ireland and contributes to preparation of new local regulatory guidance documents when applicable.
• Management of initial Marketing Authorisation (MA) applications, Variations, and other MA maintenance applications.
• Timely and compliant filing of clinical trial applications, amendments, and other clinical trials submissions.
• Reviewer for promotional and non-promotional activities and materials and ensuring their compliance with the licence, local guidance, codes of conduct and 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 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 contribute 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 in accordance with product SmPCs
• Develop expertise in assign Therapeutic Area, and become Subject Matter Expert (SME) for assigned core Regulatory activities

Experience & Skills

Requires a minimum of 5 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 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 in accordance with the UK   and Irish industry codes of practice would be advantageous