Senior Regulatory Affairs Director - Guildford
Find your place and use your experience to make an impact.
ELIQUENT Life Sciences is built on the foundation of five legacy global life science consultancies. RApport Global is now working together as an aligned, coordinated regulatory team. ELIQUENT delivers comprehensive solutions that support pharmaceutical, biotechnology, medical device, and combination product companies navigating the complex regulatory landscape.This unprecedented assembly of regulatory experts enables a unique understanding of the life sciences industry, and the unmatched expertise companies need when navigating today’s evolving regulatory environment.
The ELIQUENT team continues to grow from strength to strength, with the team applying our latest thinking in creating the next generation of regulatory solutions that deliver value to some of the largest organisations in our industry. We help our clients to solve their regulatory challenges by developing bespoke solutions that meet their unique needs.
Our team operates at a global level. There is plenty to learn, space to develop and make a real contribution with an opportunity to participate in a wide range of engagements.
The Opportunity
Senior Regulatory Affairs Director
We are seeking a dynamic and experienced Senior Regulatory Affairs Director to be a senior representative for Regulatory Affairs for clients’ senior management and operational teams within the UK, Europe and Internationally. You will use your client interactions and network to explore opportunities for business development.The Senior Regulatory Affairs Director will report to the Co-CEO or VP, with work assignments potentially coming from other designated team members. Experience in cell and gene therapy is highly desired.
What you’ll do
As a Senior Regulatory Affairs Director you will lead, manage, and provide regulatory expertise while developing and implementing regulatory strategies in multiple regions and agency interactions. Key responsibilities include:
- Work independently on client projects, collaborating with the team and communicate with directors and senior management without direct supervision.
- Manage and deliver client projects to a high quality within timelines.
- Develop scopes of work for new projects with clients and senior management.
- Oversee employees, including performance reviews and support career development.
- Lead internal initiatives for growth and development of ELIQUENT, the Regulatory Practice, and the EU team.
- Represent ELIQUENT at conferences and client calls, including business development.
- Advise on regional strategy considerations and collaborate with regional stakeholders.
- Manage regional leads or support roles in strategy development and executing plans.
- Handle regulatory submissions in compliance with global and local requirements.
- Develop and implement regulatory strategies and processes in accordance with national legislation.
- Lead the development of regional regulatory documents and meetings.
- Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plans).
- Co-ordinate licensing and post licensing procedures on behalf of clients, i.e. Clinical Trial Applications, National, Mutual Recognition and Centralised Applications.
- Direct research activities for regulatory strategy documents and horizon scanning activities.
- Communicate effectively with clients Facilitate teamwork and training to share experiences and learning.
About you
Senior Regulatory Affairs Directors are pivotal in project managing client deliverables, utilising ELIQUENT’s internal and external resources to meet client expectations with the highest quality within set timelines. Qualified candidates must meet the following criteria:
- Minimum College or University degree (or part way through) in a relevant discipline (e.g. Biology, Chemistry or Pharmacy).
- Significant experience as a senior regulatory professional in pharma, biotech, or consultancy. Experience in cell and gene therapy is highly desired.
- Broad regulatory experience in developing, managing and executing regulatory plans for pre- and post-approval activities and managing teams.
- Preferably direct line management experience.
- Global experience with European and US regulatory requirements, including early access pathways.
- Proven track record in managing internal and external resources for complex regulatory projects.
- Excellent organisational skills and time management skills with strong attention to detail.
- Ability to thrive in fast-paced, dynamic environments, managing multiple projects and multiple tasks, and working in a matrix environment.
Our commitment to you
A career at ELIQUENT is an opportunity to hone your skills and develop in the direction you choose. Join us and you’ll experience a purpose you can believe in and an impact you can see.
We’re committed to building a culture that empowers all our people to thrive and feel a sense of belonging at ELIQUENT. We invest in outstanding people, building a team of future thinkers from diverse backgrounds, empowering them to achieve their potential.
What makes ELIQUENT a great place to work?
We will empower you to choose the working pattern that works best for you and how you work best, to be collaborative, learn from the team, share your experience and insight, build relationships that drive your career and prioritise your wellbeing.We offer an environment where you can experience a purpose you believe in, the freedom to bring your true self to work every day, growing and developing at a pace that’s right for you.
We believe it’s only when you’re comfortable and at your best that you can make the greatest impact on those around you.