Senior Manager - Regulatory Affairs (CTA)

Senior Manager - Regulatory Affairs

Position: Senior Manager - Regulatory Affairs
Location: City of London

Contract Length: 12-months (view to extend)

Work Structure: Monday - Friday (Hybrid)

Pay Rate: Inside IR35

Senior Manager Regulatory Affairs - Overview:

• We are seeking a highly skilled and experienced Senior Manager Regulatory Affairs to join our team. This affiliate role will assist in the local coordination and execution of regulatory submissions in compliance with our corporate standards and national regulatory requirements, as well as manage Regulatory Affairs processes and deliverables for the UK and Ireland.
• The core elements of this pivotal role include supporting the local execution of the EU regional regulatory strategy, including clinical trial application (CTA) submissions, and the UK and Ireland affiliate commercial strategy with a focus on Oncology and Acute Anti-infections.

Senior Manager Regulatory Affairs - Key Responsibilities:

• Act as an expert on the regulatory environment within the UK and Ireland and contribute to the preparation of new local regulatory guidance documents when applicable.
• Manage initial Marketing Authorisation (MA) applications, Variations, and other MA maintenance applications.
• Ensure timely and compliant filing of clinical trial applications, amendments, and other clinical trial submissions.
• Review promotional and non-promotional activities and materials to ensure compliance with the license, local guidance, codes of conduct, and our SOPs.
• Establish and maintain strong relationships with all functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with our Global RA team to ensure the success of local and international business results from a regulatory perspective.
• Serve as the local GxP compliance expert, assisting with and, where appropriate, leading local regulatory activities, including internal and agency-led inspections and audits, SOP development, gap analysis, and subsequent process improvement initiatives.
• Initiate 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.
• Ensure product packaging and associated information is updated and maintained in accordance with product SmPCs.
• Develop expertise in assigned Therapeutic Areas and become a Subject Matter Expert (SME) for assigned core Regulatory activities.

Senior Manager Regulatory Affairs - Knowledge, Experience & Skills:

• Minimum of 5-10 years of experience in Regulatory Affairs, in an affiliate or global role.
• Science degree/Masters with relevant experience in Regulatory Affairs.
• Knowledge and awareness of UK/IE regulatory guidelines and legislation, with a 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 the management of CTAs, including amendments and other clinical trial-related submissions.
• Experience in GxP compliance.
• Experience in reviewing promotional and non-promotional material in accordance with UK and Irish industry codes of practice is advantageous.
• Expert project management and time management skills.
• Excellent organization skills and interpersonal skills.
• Excellent verbal and written communication skills in English.
• Recognized 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.

If you meet the above requirements, I encourage you to apply - Please send your CV and cover letter to: JManzo@i-pharmconsulting.com