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- Tasks: Lead regulatory strategy and influence clients in a high-impact role.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, private health, and flexible benefits.
- Why this job: Shape the future of medicine access 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 43200 - 72000 £ 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.
You will lead as a senior Regulatory Affairs professional in a high-impact leadership role, shaping strategy, influencing clients and driving business growth. Acting as Deputy to the Regulatory Affairs function, you will be a trusted regulatory partner to both internal stakeholders and global clients, delivering complex regulatory projects from strategy through to execution. You will guide 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.
Responsibilities
- 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
Requirements
- 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 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
✨Tip Number 1
Network like a pro! Get out there and connect with industry professionals on LinkedIn or at conferences. We all know that sometimes it’s not just what you know, but who you know that can land you that dream job.
✨Tip Number 2
Prepare for interviews by researching Clinigen and its regulatory affairs strategies. We want to see your passion for the role, so come armed with questions that show you’ve done your homework and are genuinely interested in contributing to our growth.
✨Tip Number 3
Showcase your expertise! During interviews, share specific examples of how you’ve successfully managed regulatory projects or influenced client relationships. We love hearing about real-world experiences that demonstrate your skills.
✨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, we’re always looking for candidates who are proactive and eager to join our team.
We think you need these skills to ace Senior Director Regulatory Affairs - Consulting & Client Strategy
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 client-facing roles, showcasing how you've successfully managed global projects.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for Clinigen. Use it to express your passion for regulatory affairs and how your expertise aligns with our mission of delivering compliant access to medicines.
Showcase Your Leadership Skills: As a senior professional, we want to see your leadership capabilities. Share examples of how you've developed teams or influenced stakeholders in previous roles, demonstrating your ability to drive business growth.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application gets to the right people quickly and allows us to keep track of all candidates efficiently.
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 pharmaceutical industry. Be ready to discuss specific regulations and how they impact marketing authorisations and managed access programmes. This will show that you’re not just familiar with the basics but can also navigate complex regulatory landscapes.
✨Showcase Your Leadership Skills
As a Senior Director, you'll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully led teams or projects in the past. Highlight your experience in mentoring others and how you've contributed to the growth of your previous organisations.
✨Prepare for Client Interactions
Since this role involves client-facing responsibilities, think about how you would handle various client scenarios. Be ready to discuss how you’ve built and maintained client relationships in the past, and prepare to share strategies for influencing clients effectively.
✨Communicate Clearly and Confidently
Outstanding communication skills are crucial for this position. Practice articulating your thoughts clearly and confidently, both verbally and in writing. You might even want to prepare a short presentation on a relevant topic to showcase your ability to convey complex information in an understandable way.
