Competitive Salary & Company Benefits | Petersfield/Leicester UK Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day) Are you looking to work for a rapidly growing UK Pharmaceutical company that is passionate about improving patients lives across the world? Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business has a highly diversified portfolio of more than 250 products across several categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS, and dermatology. Do you want to be part of the journey? If so, here is your chance The Role We are seeking a dynamic and experienced Sr. Director, Head of Regulatory Affairs to lead Aspire Pharmas regulatory strategy, ensuring the timely approval and compliance of our pharmaceutical products. This includes a diverse portfolio ranging from generics and complex formulations to biosimilars and medical devices. Reporting to the Chief Medical Officer and leading a team of 4-6 professionals, you will oversee regulatory evaluation, submissions, lifecycle management, and post-marketing activities while driving alignment with global and regional regulatory standards. What will you be doing? Regulatory Strategy Development: - Lead and execute Aspire Pharmas regulatory strategy for generics, biosimilars, complex generics, and medical devices. - Align regulatory activities with business objectives and market-specific requirements. - Provide strategic oversight of regulatory submissions, product registrations, and approvals across various markets (UK, Europe, RoW). Regulatory Compliance & Risk Management: - Govern compliance with GMP, GCP, and other regulatory standards. - Develop risk management frameworks to address potential regulatory challenges proactively. Lifecycle Management & Post-Marketing: - Manage the lifecycle of approved products, ensuring timely regulatory submissions for changes and variations. - Oversee labeling updates and other post-marketing activities. External Stakeholder Engagement: - Build and maintain strong relationships with key regulatory bodies, such as EMA, MHRA, and WHO. - Act as the primary contact with regulatory authorities and represent the company in external forums. Team Leadership: - Develop and lead a high-performing regulatory affairs team with expertise in international and regional frameworks. - Foster a culture of continuous improvement within the regulatory function. The Person - Advanced degree in Pharmaceutical Sciences or related field (Masters/Ph.D. preferred). - Extensive experience in regulatory affairs with significant leadership experience. - Proven track record of securing regulatory approvals across markets, particularly in generics, biosimilars, or complex formulations. - Comprehensive knowledge of global and regional regulatory requirements (e.g., MHRA, EMA). - Exceptional cross-functional collaboration, communication, and leadership skills. - Strong problem-solving and risk management capabilities. Why join us? As well as a fantastic, inclusive company culture where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being, including: - Generous Pension Scheme. -Life Assurance cover and Employee Assistance Program. - 25 days holiday plus Bank Holidays. - Learning and Development opportunities. - Excellent opportunities for progression. - Fantastic company events and celebrations throughout the year. If youre ready to make a significant impact and lead our regulatory efforts to new heights, we would love to hear from you