We are delighted to be looking for a Practise Leader to join an exciting and well funded CRO as Head of Regulatory Affairs. 

Our client is new, dynamic and innovative clinical research organisation committed to providing expert consulting services to assist companies in accelerating the time to market of their investigational products. Specialising in optimising the drug development process, our team is dedicated to supporting clients seeking to blend expertise with the latest technologies to accelerate successful approval.

We are looking for a leader with a track record of setting up and developing high performing regulatory teams. You will be part of the Senior Leadership Team so you will be leading strategy too including set up activities. 

Position Overview:

As the Head of Regulatory Affairs, you will play a pivotal role in shaping the regulatory strategy of our client, contributing to the growth and success of our clients' investigational products. This leadership position requires a strategic thinker with exceptional commercial acumen, adept at client engagement, business development, and regulatory leadership. The successful candidate will be based in the UK and will lead a team of regulatory experts to ensure the seamless integration of regulatory strategies into our clients' overall business objectives. This person will also support merger and acquisition activity.

Key Responsibilities:

Regulatory Strategy Development:

Develop and implement regulatory strategies to expedite the approval process for investigational products.

Provide expert guidance on regulatory requirements and compliance to support clients in navigating complex regulatory landscapes including ICH GCP, Medical Device including AI and ML alogrithms

Leadership and Team Management:

Lead and inspire a team of regulatory affairs professionals, fostering a culture of excellence and continuous improvement.

Provide mentorship and guidance to team members, promoting their professional development.

Client Engagement and Business Development:

Build and maintain strong relationships with clients, understanding their unique needs and providing tailored regulatory solutions.

Drive business development initiatives to expand our client base and contribute to the organic growth of our client.

Merger and Acquisition Support:

Collaborate with cross-functional teams to assess regulatory aspects of potential mergers and acquisitions.

Play a key role in due diligence activities and integration efforts to ensure regulatory compliance and a smooth transition.

Commercial Skills:

Demonstrate strong commercial awareness, understanding market trends, and identifying opportunities for business expansion.

Engage in negotiations with clients, regulatory agencies, and other stakeholders to achieve favorable outcomes.

Qualifications and Experience:

Highly experienced in regulatory affairs within the pharmaceutical or healthcare industry.

In-depth knowledge of UK and international regulatory requirements and guidelines.

Proven track record of successful leadership in a regulatory affairs role, preferably in a consulting capacity.

Excellent communication and interpersonal skills with the ability to build and maintain strong client relationships.

Strong business acumen and a demonstrated ability to contribute to business development and organizational growth.

Education:

Bachelor's, Master's, or Ph.D. degree in a relevant scientific or regulatory field.

How to Apply:

Interested candidates should submit their resume and cover letter detailing their relevant experience and outlining their approach to regulatory strategy in the pharmaceutical industry. Please send applications to Gail Kniveton or reach out to me for more information.

Our client is an equal opportunity employer and welcomes applications from candidates of all backgrounds. We encourage individuals with disabilities to apply and provide any necessary accommodations during the recruitment process.

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