Regulatory Specialist

Albion Rye Associates

  • Central London
  • Contract
  • Full-time
  • 23 days ago
Senior Regulatory Affairs ManagerOnsite London – PaddingtonOverviewWe 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 QualificationsEducation:
  • 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.

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