▷ High Salary: Director of Regulatory Affairs ...

Job Description Job Title: Director of RegulatoryAffairs Location: Cambridge UK Function: Regulatory Affairs Reportsto: Chief Regulatory Officer Job Summary: The Director ofRegulatory Affairs will be responsible for the preparation,submission and management of marketing authorization applications(MAA) with a special focus on hybrid applications submitted underArticle 10(3) of Directive 2001/83/EC, for submission in the UK andEU. The applicant will be responsible for managing all regulatoryactivities pre- and post- submission. This role is critical inensuring that products meet all regulatory requirements and meetthe regulatory standards of UK and EU Health Authorities. The idealcandidate will have a strong understanding of regulatory affairsactivities related drug development of drug-device combinationproducts and related expectations under the EU Medical DeviceRegulation and UK Medical Device Regulations, dossier compilationand submission. The candidate should have a proven track record ofsuccessful regulatory submissions and interactions with regulatoryagencies. Key Responsibilities Regulatory Strategy and Compliance:Develop regulatory strategies for submissions of multiple productsin multiple regions and countries, product modifications, andlifecycle management. Ensure all regulatory activities align withcompany goals and compliance requirements. Monitor and interpretregulatory changes and trends to ensure ongoing agreement withregulatory guidances. Regulatory Submissions: Actively participatein the preparation, submission, and management of regulatoryfilings. Prepare, review and submit and manage correspondences withHealth Authorities in the UK and EU. Participate in, and overseethe preparation of dossiers with external vendors, and ensure theymeet regulatory standards and guidelines. Coordinate withcross-functional teams to compile and review submission materials.Manage Labeling activities. Serve as the primary liaison withregulatory authorities. Manage and facilitate meetings andcommunications with regulatory agencies. Address regulatory queriesand issues promptly and effectively. Cross-FunctionalCollaboration: Collaborate with Pharmaceutical Development,Clinical Development, Quality Assurance, and other departments toensure regulatory requirements are integrated into productdevelopment and lifecycle processes. Regulatory Intelligence andRisk Management: Conduct regulatory intelligence to anticipate andaddress potential regulatory challenges. Develop and implement riskmanagement strategies to address regulatory compliance issues.Documentation and Reporting: Maintain accurate and up-to-dateregulatory files and documentation. Prepare and present regulatoryupdates 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 ofexperience in regulatory affairs within the pharmaceuticalindustry. In-depth knowledge of UK and EU regulatory requirementsand standards related to drug-device combination products. Provenexperience with regulatory submissions and interactions withregulatory agencies. Self-starter with strong hands-on experienceStrong leadership, communication, and interpersonal skills. Abilityto work effectively in a fast-paced and dynamic environment.Excellent organizational and project managementskills.