Regulatory Affairs Manager

An excellent opportunity has arisen for an experienced regulatory professional to join my client, an established Regulatory consultancy, on an initial 12 month contract basis - the contract can be on a 6 or 12 month basis, full time or part time and fully remote based! The ideal person will have full life cycle experience, from CTAs through to registrations. As well as offering exposure to a broad range of projects, you will also be responsible for producing regulatory training materials for use on the other side of the business which offers courses for aspiring regulatory professionals.

Responsibilities will include:

• Regulatory Strategy & Lifecycle Management

• Strategic Guidance: Develop and implement robust EU and UK regulatory strategies for pharmaceutical and biotechnology products, from early-stage clinical development through to marketing authorisation and post-approval maintenance.
• Full Lifecycle Support: Provide expert regulatory input for First-in-Human studies, clinical trial applications (CTAs/CTIS), Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug (IND) applications, Marketing Authorisation Applications (MAAs), and post-authorisation activities (variations, renewals).
• Regulatory Intelligence: Advise clients on evolving regulatory requirements, guidelines, and best practices in the EU and UK, identifying potential risks and opportunities.
• Agency Interactions: Prepare for and participate in scientific advice meetings and other formal interactions with regulatory authorities (e.g., MHRA, EMA).

• Dossier Development: Lead or significantly contribute to the authoring, review, and compilation of high-quality regulatory dossiers and documents, ensuring compliance with relevant regulations and guidelines.
• Module 3 Expertise: Specialise in the preparation and review of Chemistry, Manufacturing, and Controls (CMC) sections (Module 3) for both clinical trial applications and marketing authorisation applications.
• Quality Assurance: Ensure all submissions are scientifically sound, well-structured, and presented in a clear, concise manner to facilitate efficient agency review.
• Response Management: Coordinate and draft responses to regulatory agency questions and deficiency letters, working collaboratively with client teams.

• Technical Translation: Translate complex manufacturing and quality data into clear, compliant regulatory submissions.
• Change Management: Provide regulatory oversight and support for manufacturing process changes, analytical method development, technology transfers, and site changes.
• Strategic Input: Offer strategic CMC input throughout product development to ensure regulatory compliance and optimise development timelines.

• Content Development: Collaborate with our training team to design, update, and enhance engaging training materials for our diverse range of regulatory affairs courses (e.g., Introduction to Regulatory Affairs, Excel, Expand programs).
• Delivery & Presentation: Deliver compelling presentations and lead interactive sessions for both our public courses and bespoke in-house client training programs.
• Mentorship: Potentially mentor junior professionals or course participants, sharing your expertise and fostering their growth in regulatory affairs.
• Thought Leadership: Contribute to our knowledge base through articles, webinars, or other content that highlights our expertise and thought leadership (optional, based on interest).

• Trusted Advisor: Serve as a primary regulatory contact for assigned clients, building strong, long-term partnerships based on trust and expertise.
• Problem Solving: Provide pragmatic, solution-oriented regulatory advice that addresses client challenges while maintaining compliance.
• Project Management: Manage regulatory projects effectively, ensuring timely delivery of high-quality work within agreed-upon scopes.

• Process Improvement: Actively contribute to the continuous improvement of our internal processes, templates, and best practices.
• Strategic Input: Provide valuable insights and feedback to help shape the development of new consulting services and training offerings.
• Team Collaboration: Work closely with a supportive and collaborative team, contributing to our vibrant company culture.