Director of Regulatory Affairs

Job Title:Director of Regulatory Affairs

Location:Cambridge UK

Function:Regulatory Affairs

Reports to:Chief Regulatory Officer

Job Summary:

The Director of Regulatory Affairs will be responsible for the preparation, submission and management of marketing authorization applications (MAA) with a special focus on hybrid applications submitted under Article 10(3) of Directive 2001/83/EC, for submission in the UK and EU. The applicant will be responsible for managing all regulatory activities pre- and post- submission. This role is critical in ensuring that products meet all regulatory requirements and meet the regulatory standards of UK and EU Health Authorities.

The ideal candidate will have a strong understanding of regulatory affairs activities related drug development of drug-device combination products and related expectations under the EU Medical Device Regulation and UK Medical Device Regulations, dossier compilation and submission. The candidate should have a proven track record of successful regulatory submissions and interactions with regulatory agencies.

Key Responsibilities

Regulatory Strategy and Compliance:

Develop regulatory strategies for submissions of multiple products in multiple regions and countries, product modifications, and lifecycle management.

Ensure all regulatory activities align with company goals and compliance requirements.

Monitor and interpret regulatory changes and trends to ensure ongoing agreement with regulatory guidances.

Regulatory Submissions:

Actively participate in the preparation, submission, and management of regulatory filings.

Prepare, review and submit and manage correspondences with Health Authorities in the UK and EU.

Participate in, and oversee the preparation of dossiers with external vendors, and ensure they meet regulatory standards and guidelines.

Coordinate with cross-functional teams to compile and review submission materials.

Manage Labeling activities.

Serve as the primary liaison with regulatory authorities.

Manage and facilitate meetings and communications with regulatory agencies.

Address regulatory queries and issues promptly and effectively.

Cross-Functional Collaboration:

Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes.

Regulatory Intelligence and Risk Management:

Conduct regulatory intelligence to anticipate and address potential regulatory challenges.

Develop and implement risk management strategies to address regulatory compliance issues.

Documentation and Reporting:

Maintain accurate and up-to-date regulatory files and documentation.

Prepare and present regulatory updates and reports to senior management and other stakeholders.

Qualifications:

Bachelor’s degree in a scientific discipline; advanced degree (MS, PhD) preferred.

Minimum of 7 years of experience in regulatory affairs within the pharmaceutical industry.

In-depth knowledge of UK and EU regulatory requirements and standards related to drug-device combination products.

Proven experience with regulatory submissions and interactions with regulatory agencies.

Self-starter with strong hands-on experience

Strong leadership, communication, and interpersonal skills.

Ability to work effectively in a fast-paced and dynamic environment.

Excellent organizational and project management skills.