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For Companies At a Glance
- Tasks: Lead complex regulatory projects and prepare high-quality documents with minimal oversight.
- Company: Join a dynamic team of regulatory experts in a supportive environment in London.
- Benefits: Enjoy opportunities for mentorship, professional growth, and engaging client interactions.
- Why this job: Be a key player in global projects that impact drug development and client success.
- Qualifications: Bachelor's or Master's in Life Sciences with 8+ years in regulatory affairs required.
- Other info: Opportunity to work independently while contributing to cross-functional initiatives.
The predicted salary is between 48000 - 72000 £ per year.
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.
Regulatory Specialist employer: Albion Rye Associates
Contact Detail:
Albion Rye Associates Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Specialist
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and marketing authorisation transfer processes. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience in leading projects. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences in managing regulatory projects. Highlight your leadership skills and how you've successfully navigated complex situations, as this will resonate well with our team.
✨Tip Number 4
Showcase your ability to build client relationships by preparing anecdotes that illustrate your proactive solutions and effective communication. This is crucial for the role and will set you apart from other candidates.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in regulatory affairs, particularly any leadership roles or projects you've managed. Use specific examples that demonstrate your expertise in the drug development lifecycle and your ability to deliver high-quality outputs.
Craft a Compelling Cover Letter: In your cover letter, emphasise your experience with client engagement and project leadership. Mention how you can contribute to the company's regulatory strategy and your familiarity with regional regulatory guidelines. Make it personal and show your enthusiasm for the role.
Highlight Technical Skills: Clearly outline your technical skills in regulatory writing and your proficiency with Microsoft Office and regulatory publishing tools. Provide examples of documents you've prepared or projects you've led that showcase these skills.
Showcase Mentorship Experience: If you have experience mentoring junior team members, be sure to include this in your application. Highlight how you've contributed to their growth and development, as this aligns with the responsibilities of the role.
How to prepare for a job interview at Albion Rye Associates
✨Showcase Your Regulatory Expertise
Be prepared to discuss your in-depth knowledge of regulatory guidelines and the drug development lifecycle. Highlight specific projects where you led regulatory strategies or contributed significantly, as this will demonstrate your capability to handle complex global projects.
✨Demonstrate Leadership Skills
Since the role involves project leadership, share examples of how you've successfully led teams or initiatives in the past. Emphasise your ability to mentor junior team members and how you've contributed to their professional growth.
✨Engage with Client-Centric Examples
Prepare to discuss your experience in client engagement. Share instances where you built strong relationships with clients, provided proactive solutions, or represented your team in client meetings. This will show your ability to maintain client satisfaction and trust.
✨Prepare for Technical Discussions
Given the technical nature of the role, be ready to discuss your experience with regulatory documentation and budget oversight. Familiarise yourself with common challenges in these areas and think about how you’ve successfully navigated them in previous roles.
