Senior Director Regulatory Affairs - Consulting & Client Strategy

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 a 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 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 builds/strengthens contact with external stakeholder (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.