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- Tasks: Lead regulatory strategy and influence clients while driving business growth in a dynamic environment.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical services business.
- Benefits: Enjoy 27 days holiday, private health, flexible benefits, and annual salary reviews.
- Why this job: Make a real impact in regulatory affairs and support access to vital medicines.
- Qualifications: Bachelor's in Life Sciences and significant regulatory affairs experience 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.
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 in Burton upon Trent 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 Burton upon Trent
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching Clinigen and understanding their regulatory landscape. We recommend practising common interview questions and formulating your own questions to show your interest. Remember, it’s a two-way street!
✨Tip Number 3
Showcase your expertise! During interviews, be ready to discuss specific regulatory projects you've managed and how they align with Clinigen's goals. We want to see how your experience can directly contribute to their success.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in keeping you top of mind. We’re all about building relationships, so let them know you appreciate the opportunity to connect.
We think you need these skills to ace Senior Director Regulatory Affairs - Consulting & Client Strategy in Burton upon Trent
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: Since this is a senior role, emphasise your leadership experience. Share examples of how you've developed teams and influenced stakeholders, demonstrating your ability to drive business growth and support operational expansion.
Apply Through Our Website: We encourage you to apply directly through our website. This ensures your application reaches us promptly and allows you to explore more about our company culture and values while you're at it!
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 mentor your team effectively. Prepare to share instances where you've successfully managed teams or projects, highlighting your ability to influence and drive business growth while maintaining compliance.
✨Understand Clinigen's Vision
Familiarise yourself with Clinigen's services and their approach to the pharmaceutical lifecycle. Being able to articulate how your experience aligns with their goals will show that you're not just looking for any job, but that you're genuinely interested in contributing to their mission.
✨Prepare for Client-Facing Scenarios
Since this role involves significant client interaction, think about how you would handle various client situations. Prepare examples of how you've built and maintained client relationships in the past, and be ready to discuss your approach to delivering regulatory advice in a way that's clear and actionable.
