Regulatory Specialist

Albion Rye Associates; London; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading consultancy firm in London is seeking a Senior Regulatory Affairs Manager to lead complex projects and engage with clients. The ideal candidate will have at least 8 years of experience in regulatory affairs, along with a strong educational background in life sciences. Responsibilities include project leadership, technical writing, and managing client relationships. This position offers an opportunity to work in a dynamic environment with minimal supervision.

Qualifications

• Minimum 8 years of relevant experience in regulatory affairs or related field.
• Demonstrated experience in leading regulatory projects and contributing to regulatory strategies.

Responsibilities

• Lead complex regulatory projects, including technical writing and managing initiatives.
• Prepare high-quality regulatory and technical documents with minimal oversight.
• Build and maintain strong relationships with clients and represent the regulatory team.

Skills

Project Leadership

Technical Expertise

Client Engagement

Budget Oversight

Mentorship & Training

Education

Bachelor's or Master’s Degree in Life Sciences

Tools

Microsoft Office

Regulatory publishing software/tools

Job description

Senior Regulatory Affairs Manager

Onsite London – Paddington

Overview

We are seeking an experienced Senior Regulatory Affairs Specialist to join our team of regulatory experts. In this role, you’ll work independently with minimal supervision, acting as both a Regulatory Team Leader and subject matter expert across complex global projects. You’ll be a key contributor to regulatory strategy, documentation, client engagement, and project execution within a dynamic and supportive environment.

Key Responsibilities

• Project Leadership: Lead complex regulatory projects, including technical writing and/or managing standalone initiatives, with support from senior leadership when needed.
• Technical Expertise: Prepare high-quality regulatory and technical documents with minimal oversight.
• Client Engagement: Build and maintain strong relationships with clients, offering proactive solutions and representing the regulatory team in client meetings.
• Budget Oversight: Review and manage project budgets, track out-of-scope activities, ensure proper revenue recognition, and challenge deviations where appropriate.
• Mentorship & Training: Provide guidance and feedback to junior team members, contributing to their growth and development.
• Client Presentations: Participate in bid defense and client-facing meetings, both virtually and in person, showcasing regulatory deliverables.
• SOP Development: Draft, revise, or review regulatory standard operating procedures as assigned.
• Initiative Support: Contribute to regulatory or company-wide initiatives and support cross-functional collaboration where needed.
• Regulatory Agency Interaction: Manage communications and meetings with regulatory agencies when required.

Required Qualifications

Education:

• Bachelor's or Master’s Degree in Life Sciences or a related discipline.

Experience:

• Minimum 8 years of relevant experience in regulatory affairs or related field.
• Demonstrated experience in leading regulatory projects and contributing to regulatory strategies.

Knowledge & Skills:

• Strong understanding of the drug development lifecycle (CMC, preclinical, clinical).
• In-depth knowledge of regional regulatory guidelines and marketing authorization transfer (MAT) processes.
• Proven ability to plan and deliver high-quality outputs within deadlines and budget.
• Familiarity with pharmacovigilance considerations related to MATs.
• Competent in Microsoft Office and regulatory publishing software/tools.
• Ability to manage multiple concurrent projects with a strategic mindset.
• Comfortable working within SOP frameworks and contributing to process improvements.
• Experience supporting regulatory submissions and leading client engagements.