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- Tasks: Lead regulatory strategy for innovative therapies and ensure compliance across multiple products.
- Company: Join a global pharmaceutical company dedicated to excellence in healthcare.
- Benefits: Enjoy remote work flexibility with occasional travel to London for key meetings.
- Why this job: Be part of a passionate team focused on delivering high-quality regulatory guidance and best practices.
- Qualifications: Significant experience in Regulatory Affairs within the pharmaceutical industry is essential.
- Other info: This role offers a chance to influence product development and engage with regulatory agencies.
The predicted salary is between 48000 - 84000 £ per year.
A global pharmaceutical company based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.
You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products.
This is a great opportunity to work with a team who take provide in working to the highest standards, passionate about delivering excellence and focused on sharing regulatory best practice and guidance throughout the wider business.
Working with the regulatory team (and core stakeholders across multiple areas), your role will be to operate as a Regulatory Lead, providing centralised regulatory strategy and guidance across the region and make sure that regulatory deadlines and approvals are achieved.
The role is largely remote but travel to the office (London) will be expected for key meetings. The preference would therefore be for someone to be based in a 50 miles radius of London.
Other responsibilities include:
- You will develop, contribute and ensure the accurate preparation of high-quality regulatory documents needed to support clinical trials and medical products.
- Contributing regulatory guidance in order to enhance product development.
- As the regulatory lead, you will sit with the wider project team, providing guidance on how regulatory strategy should be implemented.
- Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements.
- Acting as a point of contact between the company and regulatory agencies whilst pertaining important information.
Requirements
- Significant Regulatory Affairs experience within pharmaceutical industry – essential.
- Proven experience as a Regulatory Lead managing at least one product end to end lifecycle.
- Preferably significant EU regulatory affairs exposure.
- Able to clearly demonstrate experience in developing centralised regulatory plans and strategy.
- Strong communication and stakeholder management experience; you will be able to demonstrate working in project teams, where you have guided/advised on the implementation of your strategy/regulatory plan.
- Strong strategic experience within Regulatory Affairs.
- Exposure to Regulatory Affairs full cycle and submissions procedures such as CTA, PIPs, ODDs, and MAAs is advantageous.
- Exposure of Regulatory Affairs legislation and procedures.
- Strong communication and interpersonal skills.
Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.
Senior Regulatory Affairs Manager employer: Park Street People
Contact Detail:
Park Street People Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Affairs Manager
✨Tip Number 1
Make sure to familiarize yourself with the latest EU regulatory guidelines and frameworks. 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 pharmaceutical industry, especially those who have experience in regulatory affairs. Attend relevant conferences or webinars to connect with potential colleagues and learn about best practices.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed regulatory strategies in previous roles. Highlight your experience with product lifecycle management and how you navigated challenges.
✨Tip Number 4
Since the role involves remote work with occasional travel, be ready to talk about your experience in managing remote teams or projects. Emphasize your communication skills and how you ensure collaboration across distances.
We think you need these skills to ace Senior Regulatory Affairs Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your significant Regulatory Affairs experience within the pharmaceutical industry. Emphasize your role as a Regulatory Lead and any relevant experience managing product lifecycles.
Craft a Strong Cover Letter: In your cover letter, clearly demonstrate your ability to develop centralized regulatory plans and strategies. Mention specific examples of how you've guided project teams in implementing regulatory strategies.
Highlight Communication Skills: Since strong communication and stakeholder management are crucial for this role, provide examples in your application that showcase your interpersonal skills and experience working with regulatory agencies.
Showcase Relevant Experience: If you have exposure to EU regulatory affairs or experience with submissions procedures like CTA, PIPs, ODDs, and MAAs, make sure to highlight this in your application. It will strengthen your candidacy.
How to prepare for a job interview at Park Street People
✨Showcase Your Regulatory Expertise
Be prepared to discuss your significant experience in Regulatory Affairs, especially within the pharmaceutical industry. Highlight specific examples where you successfully managed a product's lifecycle and developed centralized regulatory plans.
✨Demonstrate Strong Communication Skills
Since this role requires strong communication and stakeholder management, practice articulating your experiences in project teams. Share instances where you provided guidance on regulatory strategies and how you effectively communicated with various stakeholders.
✨Understand the Company's Regulatory Environment
Research the company's products and their regulatory landscape. Familiarize yourself with relevant EU regulations and be ready to discuss how your knowledge can contribute to the company's strategic goals and compliance.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory affairs. Think of situations where you had to navigate complex regulatory challenges and how you approached them to ensure compliance and timely approvals.
