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- Tasks: Lead regulatory strategy and manage complex projects in a dynamic pharmaceutical environment.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, private health, flexible benefits, and a discretionary bonus.
- Why this job: Shape the future of healthcare by influencing clients and driving business growth.
- Qualifications: Significant regulatory affairs experience and strong communication skills required.
- Other info: Be part of a supportive team with excellent career development opportunities.
The predicted salary is between 72000 - 108000 £ 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.
Leadership
- 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.
Regulatory Intelligence and 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.
Qualifications
- 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.
Benefits
- 27 days holiday, plus bank holidays.
- Discretionary Bonus.
- Private Health.
- Pension contributions & Life Assurance scheme.
- Flexible Benefits Platform.
- Annual salary review.
- Independent financial advice service.
- 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 - Consulting & Client Strategy in Weybridge employer: Clinigen
Contact Detail:
Clinigen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Regulatory Affairs - Consulting & Client Strategy in Weybridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, especially those who might know someone at Clinigen. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching Clinigen's recent projects and regulatory challenges. Show us you’re not just another candidate; demonstrate your knowledge and how you can contribute to their growth.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the role of Senior Director in Regulatory Affairs. We want to hear how you can shape strategy and drive business growth.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the Clinigen team.
We think you need these skills to ace Senior Director Regulatory Affairs - Consulting & Client Strategy in Weybridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Director Regulatory Affairs role. Highlight your relevant experience in regulatory affairs and how it aligns with Clinigen's needs. We want to see how you can shape strategy and drive business growth!
Showcase Your Leadership Skills: Since this is a high-impact leadership role, don’t forget to emphasise your experience in managing teams and projects. Share examples of how you've nurtured talent and delivered results in previous roles. We love seeing strong leaders in action!
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to convey your regulatory expertise and commercial awareness. We appreciate well-structured applications that get straight to the heart of your qualifications.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of being considered. It’s the easiest way for us to track your application and ensure it gets the attention it deserves. Don’t miss out on this exciting opportunity!
How to prepare for a job interview at Clinigen
✨Know Your Regulatory Stuff
Make sure you brush up on your regulatory affairs knowledge, especially around European procedures and marketing authorisations. Be ready to discuss specific examples from your past experience that demonstrate your expertise in navigating complex regulatory landscapes.
✨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 influence clients and internal stakeholders effectively.
✨Understand Clinigen's Business Model
Familiarise yourself with Clinigen’s services and how they fit into the pharmaceutical lifecycle. Be prepared to discuss how your role can contribute to their growth and how you can help shape their regulatory strategy to support business development.
✨Prepare for Client-Facing Scenarios
Since this role involves significant client interaction, think about how you would handle various client scenarios. Prepare to discuss your approach to building relationships and providing regulatory advice that aligns with client needs while ensuring compliance.
