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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.
- Benefits: Enjoy opportunities for mentorship, client engagement, and professional growth.
- Why this job: Be a key contributor to global projects and make a real impact in the industry.
- Qualifications: Requires a Bachelor's or Master's in Life Sciences and 8 years of relevant experience.
- Other info: Opportunity to work onsite in London and engage with regulatory agencies.
The predicted salary is between 48000 - 72000 £ per year.
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.
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 frameworks relevant to the role. This will not only help you in interviews but also demonstrate your commitment to staying updated in a fast-evolving 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 to achieve results.
✨Tip Number 4
Showcase your ability to build client relationships by preparing anecdotes that illustrate your proactive approach in previous roles. This will be crucial in demonstrating your fit for the client engagement aspect of the job.
We think you need these skills to ace Regulatory Specialist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Senior Regulatory Affairs Specialist position. Tailor your application to highlight relevant experience and skills that align with the job description.
Craft a Strong CV: Your CV should clearly outline your educational background, relevant work experience, and specific achievements in regulatory affairs. Emphasise your leadership roles and any experience with regulatory submissions or client engagement.
Write a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Highlight your technical expertise and project leadership experience, and explain how you can contribute to their regulatory strategy and client relationships.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at Albion Rye Associates
✨Showcase Your Regulatory Expertise
Be prepared to discuss your experience in regulatory affairs, particularly your understanding of the drug development lifecycle and regional regulatory guidelines. Highlight specific projects where you led initiatives or contributed to regulatory strategies.
✨Demonstrate Leadership Skills
Since the role involves project leadership, share examples of how you've successfully managed complex regulatory projects. Discuss your approach to mentoring junior team members and how you've fostered collaboration within teams.
✨Engage with Client Scenarios
Prepare for questions about client engagement by thinking of instances where you built strong relationships with clients. Be ready to explain how you provided proactive solutions and represented your team effectively in meetings.
✨Discuss Budget Management Experience
As budget oversight is a key responsibility, be ready to talk about your experience in managing project budgets. Provide examples of how you've tracked out-of-scope activities and ensured proper revenue recognition in past roles.
