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- Tasks: Lead regulatory strategies and manage submissions for innovative biopharma products.
- Company: Join a leading multi-national biopharma company with a collaborative culture.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in the biopharma industry while developing your regulatory expertise.
- Qualifications: Experience in regulatory affairs and knowledge of regional legislation required.
- Other info: 12-month contract with potential for career advancement in a dynamic environment.
The predicted salary is between 48000 - 72000 £ per year.
PE Global is currently recruiting for a Sr Manager Regulatory Affairs for a leading multi-national Biopharma client based in Uxbridge/Cambridge. The position is an initial 12 month contract position, inside IR35. The position is hybrid with onsite meetings once a month.
Please note: our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in the UK.
Responsibilities- Advising the GRT on regional considerations in developing strategy ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- May manage one or more regional leads or support roles.
- Plans and manages regulatory submissions (e.g. clinical trial and marketing applications).
- Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
- Leads development of regional regulatory documents and meetings in accordance with GRT strategy.
- Provides regulatory direction on regional regulatory mechanisms to optimize product development.
- Directs the development of the regional product label by collaborating with the Labelling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
- Manages regional label negotiation activities with minimal supervision, participates in the development and execution of regional regulatory product strategies.
- Estimates the likelihood of regulatory success based on proposed strategies.
- Communicates and ensures alignment of regional management before GRT strategy decisions.
- Manages core regulatory activities to ensure effective regional agency interactions consistent with the Global Regulatory strategy.
- Provides managerial leadership & direction to assigned team allowing appropriate prioritization of resources to achieve goals.
- Regulatory knowledge in regional legislation.
- Working with policies, procedures and SOPs.
- Experience with national legislation and regulations relating to medicinal products.
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
- Understanding of drug development.
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage.
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes.
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.
Interested candidates should submit an updated CV.
Senior Manager Regulatory Affairs in Cambridge employer: PE Global
Contact Detail:
PE Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager Regulatory Affairs in Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Senior Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regional legislation and regulatory processes. We recommend practising common interview questions and having examples ready that showcase your experience in managing regulatory submissions.
✨Tip Number 3
Showcase your leadership skills! Be ready to discuss how you've directed teams and prioritised resources in past roles. We want to see how you can lead a team effectively in a fast-paced environment like biopharma.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re here to help you every step of the way, so make sure you take advantage of all the resources we offer.
We think you need these skills to ace Senior Manager Regulatory Affairs in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Manager Regulatory Affairs role. Highlight your relevant experience in regulatory submissions and strategy development, as well as any leadership roles you've held. We want to see how your background aligns with the job description!
Showcase Your Regulatory Knowledge: Demonstrate your understanding of regional legislation and regulatory procedures in your application. Use specific examples from your past experiences to show how you’ve navigated complex regulatory environments. This will help us see your expertise in action!
Be Clear and Concise: When writing your application, keep it clear and to the point. Avoid jargon and make sure your key achievements stand out. We appreciate straightforward communication that gets right to the heart of your qualifications.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the whole process smoother for everyone involved.
How to prepare for a job interview at PE Global
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regional legislation and regulatory procedures. Be ready to discuss specific examples from your experience that demonstrate your understanding of clinical trial applications and marketing submissions.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to lead teams effectively. Prepare to share instances where you've successfully managed a team or project, highlighting how you prioritised resources and resolved conflicts to achieve goals.
✨Align with the Company’s Strategy
Familiarise yourself with the company’s global regulatory strategy and be prepared to discuss how you can contribute to it. Think about how your past experiences align with their objectives and how you can help optimise product development.
✨Ask Insightful Questions
Prepare thoughtful questions about the role and the company’s regulatory challenges. This shows your genuine interest in the position and helps you gauge if the company is the right fit for you.
