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- Tasks: Lead regulatory strategy and guide product development in a dynamic environment.
- Company: Proclinical, a leading life sciences recruiter with a global reach.
- Benefits: Competitive salary, career growth opportunities, and a collaborative team culture.
- Why this job: Make a real impact in the pharmaceutical industry while working with innovative teams.
- Qualifications: Strong knowledge of regulatory legislation and experience in the pharmaceutical or biotech sector.
- Other info: Join a supportive team and help shape the future of healthcare.
The predicted salary is between 36000 - 60000 £ per year.
Are you ready to lead regional regulatory strategy and guide multiple products as the next Senior Manager of Regulatory Affairs? Proclinical is seeking a Senior Manager in Regulatory Affairs to support one or more products from a regional regulatory perspective. In this role, you will collaborate with global and regional teams to develop and execute regulatory strategies, ensuring compliance and effective agency interactions. This position involves guiding product development, managing submissions, and maintaining licenses for investigational and approved medicinal products.
Responsibilities:
- Advise the Global Regulatory Team (GRT) on regional considerations and ensure alignment with regional needs.
- Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with global and local requirements.
- Develop and implement regional regulatory strategies and processes in line with national legislation.
- Lead the creation of regional regulatory documents and participate in meetings aligned with GRT strategy.
- Provide guidance on regional regulatory mechanisms to optimize product development, such as expedited studies, orphan drug designations, and paediatric plans.
- Collaborate with the Labelling Working Group to develop and negotiate regional product labels.
- Coordinate responses to regulatory authority requests and communicate strategies effectively.
- Assess regulatory risks and success likelihood, providing insights to the GRT and management.
- Ensure compliance with regulatory commitments, including post-marketing commitments and paediatric plans.
- Maintain awareness of evolving legislation, regulatory policies, and competitor activities.
- Act as a point of contact for regulatory agencies, documenting and communicating outcomes of interactions.
- Support collaboration between regional leads and management to address program issues.
- Provide leadership and direction to assigned team members, prioritizing resources effectively.
Key Skills and Requirements:
- Strong knowledge of regional regulatory legislation and procedures, including CTAs, MAs, post-approval changes, extensions, and renewals.
- Experience with regulatory processes and compliance in the pharmaceutical or biotechnology industry.
- Comprehensive understanding of drug development and regulatory touchpoints.
- Ability to resolve conflicts and develop actionable solutions.
- Awareness of cultural sensitivities and ability to work across international borders.
- Excellent communication and collaboration skills to align with global and regional teams.
- Familiarity with regulatory research and ability to evaluate the impact of regulations and guidance.
UK CW Regulatory Affairs Senior Manager in Uxbridge employer: Proclinical Group
Contact Detail:
Proclinical Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land UK CW Regulatory Affairs Senior Manager in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory strategies and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your pitch! Be clear about your skills and how they relate to the role of Senior Manager in Regulatory Affairs. Confidence is key, so rehearse until you can deliver it smoothly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace UK CW Regulatory Affairs Senior Manager in Uxbridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs. We want to see how your skills align with the specific requirements of the Senior Manager role, so don’t hold back on showcasing your relevant achievements!
Showcase Your Knowledge: Demonstrate your understanding of regional regulatory legislation and procedures in your application. We’re looking for someone who knows their stuff, so include examples of how you've navigated complex regulatory landscapes in the past.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. We appreciate clarity, so avoid jargon and ensure your key messages come through loud and clear. This will help us see your communication skills right from the start!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding your application status!
How to prepare for a job interview at Proclinical Group
✨Know Your Regulatory Stuff
Make sure you brush up on regional regulatory legislation and procedures. Familiarise yourself with CTAs, MAs, and post-approval changes. Being able to discuss these confidently will show that you're the right fit for the Senior Manager role.
✨Showcase Your Collaboration Skills
This role involves working closely with global and regional teams, so be ready to share examples of how you've successfully collaborated in the past. Highlight your communication skills and any experience you have in negotiating or aligning strategies across different cultures.
✨Prepare for Scenario Questions
Expect questions about how you'd handle specific regulatory challenges or conflicts. Think of scenarios where you've had to develop actionable solutions or assess regulatory risks, and be prepared to discuss your thought process and outcomes.
✨Stay Updated on Industry Trends
Demonstrate your awareness of evolving legislation and competitor activities. Bring up recent changes in regulations or notable industry news during the interview to show that you're proactive and engaged in the field.
