Regulatory Affairs Manager

Proclinical is seeking a dedicated and experienced Manager for Regulatory Affairs. This role will focus on the local coordination and execution of regulatory submissions in compliance with corporate standards and national regulatory requirements. The successful candidate will support the local execution of the EU regional regulatory strategy, including clinical trial application submissions and the affiliate commercial strategy with a focus on Oncology and Acute Anti-infections.

Responsibilities:

• Assist in the preparation of new local regulatory guidance documents.
• Manage initial Marketing Authorisation applications, Variations and other MA maintenance applications.
• Ensure timely and compliant filing of clinical trial applications, amendments, and other clinical trials submissions.
• Review promotional and non-promotional activities and materials for compliance.
• Establish and maintain strong relationships with all functional areas of the local organisation.
• Assist with local regulatory activities, including internal and agency lead inspections and audits, SOP development, gap analysis and subsequent process improvement initiatives.
• 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 Area, and become Subject Matter Expert for assigned core Regulatory activities.

Key Skills and Requirements:

• Masters in science and relevant experience in Regulatory Affairs.
• Knowledge and awareness of UK/IE regulatory guidelines and legislation.
• Understanding of filing national variations with MHRA.
• Proven knowledge of managing 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.
• Excellent project management, time management, organisation skills and interpersonal skills.
• Excellent verbal and written communication skills in English.

Interested or know someone who might be? Reach out to Caitlin Siljeur using the following:

✉️ c.siljeur@proclinical.com

📞 020 3148 8378

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.