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For Companies At a Glance
- Tasks: Lead complex regulatory projects and shape strategy for global clients.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy a competitive salary, private health, pension contributions, and flexible benefits.
- Why this job: Make a real impact in regulatory affairs while driving business growth.
- Qualifications: Bachelor's in Life Sciences and significant regulatory affairs experience required.
- Other info: Dynamic environment with opportunities for professional development and recognition.
The predicted salary is between 36000 - 60000 £ per year.
Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.
We have a newly created high-impact leadership role for a senior Regulatory Affairs professional who wants to shape strategy, influence clients and drive business growth. Acting as Deputy to the Regulatory Affairs function, you will be a trusted regulatory partner to both internal stakeholders and global clients, leading the delivery of complex regulatory projects from strategy through to execution.
You will play a pivotal role in guiding regulatory pathways for marketing authorisations and managed access programs, while also supporting business development by helping win and grow client relationships. Combining deep regulatory expertise with commercial awareness, you will translate regulatory intelligence into clear, actionable advice that enables compliant, timely access to medicines and supports Clinigen’s continued growth.
Operational- Act as the deputy for Regulatory Affairs function.
- Assist in managing the workload and resource levels needed to support the business division.
- Represent Clinigen professionally in external meetings in a variety of contexts (regulatory authorities, conferences, business meetings).
- Delivery of department-relevant projects to meet business needs.
- Responsible for allocated products including applications for marketing authorizations in new territories and maintenance of existing licences.
- Responsible for the provision of regulatory affairs support for allocated projects such as Managed Access programs, commercial partnerships, standalone projects.
- Responsible for supporting regulatory Due Diligence of potential acquisitions/partnered product opportunities etc.
- Responsible for supporting the development of regulatory strategies and provision of regulatory advice internally and externally.
- Support the operational growth and expansion of the PV/MI/RA division in line with the company’s strategy.
- Develop and nurture the Regulatory Affairs team to consistently provide high standard regulatory support across all business divisions.
- Be a key client contact to represent Clinigen externally and deliver client projects.
- Promote and act to protect patient and public health and regulatory compliance.
- Ensure that all regulatory activities comply with current Regulatory Agencies’ requirements and guidelines.
- Support the maintenance of the Regulatory Intelligence repository for the supply of unlicensed medicines.
- Ensure Regulatory Intelligence updates are effectively communicated within the company highlighting business impact to help ensure regulatory compliance and proper planning.
- Proactively build/strengthen contact with external stakeholders (Regulatory Agency, external experts, commercial partners etc.) to help achieve strategic goals and objectives.
- Contribute to company SOPs for PV/MI/RA.
- Bachelor's Degree in Life Sciences or scientific discipline.
- Significant experience gained working in Regulatory Affairs within pharmaceutical industry/CRO.
- Relevant experience in a client facing role.
- Wide experience and knowledge of Regulatory Affairs with an excellent grounding in European procedures and ideally exposure to medicines access i.e. expanded access/compassionate use/ drug development or RoW experience.
- Understanding of clinical research and clinical trials.
- Demonstrate ability to deliver results to the appropriate quality, budget and timeline metrics.
- Proven ability to successfully manage global regulatory projects.
- Proven ability to provide coaching, advice and mentoring in areas of Regulatory Affairs.
- Excellent organisational and project management skills.
- Confident dealing with managers and employees at all levels.
- Outstanding written, verbal and interpersonal communications skills.
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
- Ability to be effective in the business development setting, with strong presentation skills.
- Effective communicator and influencer across all mediums.
Discretionary Bonus, Private Health, Pension contributions & Life Assurance scheme, Flexible Benefits Platform, Annual salary review, Enhanced Employee Assistance Programme, Shopping discounts with retailers, Long service awards, Recognition scheme & employee of the year awards.
Interested? We would love to hear from you, please apply today for consideration.
Senior Director Regulatory Affairs in Weybridge employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Regulatory Affairs in Weybridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs space and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your regulatory knowledge and understanding Clinigen's business model. Show them you’re not just another candidate; you’re someone who can drive their growth with your expertise.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website for a smoother process! It’s the best way to ensure your application gets the attention it deserves. Plus, we love seeing candidates who take that extra step!
We think you need these skills to ace Senior Director Regulatory Affairs in Weybridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Director Regulatory Affairs role. Highlight your relevant experience in regulatory affairs and any leadership roles you've held. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for Clinigen. Share specific examples of how you've influenced clients and driven business growth in your previous roles.
Showcase Your Regulatory Expertise: In your application, don't forget to showcase your deep regulatory expertise. Mention any specific projects or strategies you've led that demonstrate your ability to navigate complex regulatory pathways and ensure compliance.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Clinigen
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the context of European procedures and marketing authorisations. Be ready to discuss specific examples from your past experience that demonstrate your expertise and how it can benefit Clinigen.
✨Showcase Your Leadership Skills
As a Senior Director, you'll need to lead and nurture a team. Prepare to share your leadership philosophy and provide examples of how you've successfully managed teams or projects in the past. Highlight your ability to mentor others and drive results.
✨Understand Clinigen's Vision
Familiarise yourself with Clinigen’s mission and recent developments in the pharmaceutical industry. Be prepared to discuss how your background aligns with their goals and how you can contribute to their growth and expansion.
✨Practice Your Communication Skills
Since this role involves interacting with clients and regulatory authorities, practice articulating complex regulatory concepts clearly and concisely. Think about how you can convey regulatory intelligence in a way that is actionable and easy to understand for various stakeholders.
