At a Glance
- Tasks: Lead regulatory strategies and manage submissions for innovative biopharma products.
- Company: Join a leading multi-national biopharma company with a dynamic work culture.
- Benefits: Competitive pay, hybrid working model, and opportunities for professional growth.
- Other info: Initial 12-month contract with potential for career advancement.
- Why this job: Make a real impact in the biopharma industry while developing your leadership skills.
- Qualifications: Experience in regulatory affairs and strong leadership abilities required.
The predicted salary is between 60000 - 84000 £ per year.
PE Global is currently recruiting for a Sr Manager Regulatory Affairs for a leading multi-national Biopharma client based in Uxbridge/Cambridge. This is an initial 12 month contract position Inside IR35. The position is hybrid, with onsite meetings once a month. Pay rate is £47.19ph PAYE or £63.36ph Umbrella.
Please note: Our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in the UK.
Duties of the role/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.
Senior Manager Regulatory Affairs employer: PE Global
PE Global is an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation in the biopharma sector. With a strong focus on employee growth, our hybrid working model allows for flexibility while maintaining essential onsite interactions, ensuring that our team members thrive both professionally and personally. Join us in Uxbridge/Cambridge, where you will be part of a leading multi-national company dedicated to making a meaningful impact in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager Regulatory Affairs
✨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 regulatory strategies. We recommend practising common interview questions and scenarios related to regulatory submissions, as this will show you’re ready to hit the ground running.
✨Tip Number 3
Don’t forget to showcase your leadership skills! When discussing your experience, highlight instances where you’ve successfully managed teams or projects. We want to see how you can lead the charge in regulatory affairs.
✨Tip Number 4
Apply through our website for the best chance at landing the job! We make it easy for you to submit your application directly, ensuring it gets into the right hands quickly. Let’s get you that Senior Manager position!
We think you need these skills to ace Senior Manager Regulatory Affairs
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 what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this position. Mention specific examples of how you've successfully managed regulatory processes or led teams in the past. Let us know what excites you about working with us at StudySmarter!
Showcase Your Communication Skills:In regulatory affairs, communication is key. Make sure to demonstrate your ability to communicate complex information clearly in your application. Whether it's through your CV or cover letter, we want to see how you can effectively convey your ideas and collaborate with stakeholders.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company culture and values!
How to prepare for a job interview at PE Global
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and practices relevant to the biopharma industry. Familiarise yourself with the specific regulations that apply to the UK market, as well as any recent changes that could impact your role.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your ability to lead teams and manage projects effectively. Prepare examples from your past experiences where you've successfully guided a team through regulatory submissions or strategic planning.
✨Understand the Company’s Strategy
Research PE Global and their client’s mission, values, and recent developments in the biopharma sector. Being able to discuss how your experience aligns with their goals will show that you're genuinely interested and invested in the role.
✨Prepare for Scenario Questions
Expect to be asked about how you would handle specific regulatory challenges or scenarios. Think through potential situations you might face in this role and prepare structured responses that highlight your problem-solving skills and strategic thinking.
