Head Of Regulatory Affairs

RPH Pharmaceuticals, part of the Recipharm Group, is seeking an experienced and strategic Head of Regulatory Affairs to join our team. RPH Pharmaceuticals is a company focusing on developing and managing our own portfolio of pharmaceutical products. The role is responsible for leading Regulatory Affairs. The role has direct oversight of all regulatory activities including full life cycle management and compliance, to support safe and effective product development and market continuity.

This role is critical to ensuring the company meets global regulatory standards.

• To lead, mentor and develop a team of regulatory professionals to ensure that the business needs and departmental objectives are met.
• To provide regulatory strategic input into product selection, development and lifecycle planning across the portfolio.
• To provide regulatory guidance to both internal and external development sites in terms of all aspects of product development.
• To lead, develop and implement regulatory strategy for new and existing products within the pipeline and portfolio to meet corporate goals and objectives.
• Oversee the preparation/submission/maintenance of new Marketing Authorisation Applications in UK, EU and other International markets as required.
• Direct the planning, preparation, and delivery of submissions throughout the product's life cycle including briefing documents, INDs, CTAs and annual reports.
• To lead interactions with health authorities including scientific advice meetings for pipeline.
• Identify potential regulatory risks to the strategic/operational plans and recommend migration strategies.
• Maintain regulatory oversight and guidance to project teams on compliance matters, FDA, EMA, and other competent authority requirements and on timing, logistics and operational recommendations for product development.
• To lead the interaction with Regulatory Authorities, clients and stakeholders concerning development, registration, and lifecycle management of products in any area of the Company's business.
• Interpret applicable regulations and guidelines and keep abreast of regulatory decisions, issues, potential problems, and new regulations.
• Maintain a high level of professional expertise through continuous learning, familiarity with guidelines, scientific literature and participation in training courses.
• Drive the departmental budget definition process and ensure compliance in department budget execution.
• Represent the company in industry associations to stay abreast of industry trends and contribute to shaping regulatory and quality standards.
• Continuous Improvement:
  Identify areas for process improvements and work with relevant teams to enhance efficiency and productivity.
• Act as a strategic advisor to senior leadership on regulatory matters, identifying risks and opportunities impacting business objectives.

• 10-15 years of progressive regulatory affairs experience in the pharmaceutical or biotech industry.
• At least 5 years in leadership/management roles, overseeing regulatory teams or project teams.
• Demonstrated experience with European procedures and health authority interactions with specific emphasis on generic applications. Experience with International markets preferred, though not required.
• Proven ability to develop regulatory strategy and guide cross-functional teams through product development and lifecycle management.
• Experience in negotiating with regulatory authorities at both strategic and product level.
• Proven ability to inspire, mentor, and lead teams by example, fostering a culture of accountability and excellence.
• Self-motivated with a positive attitude and a "can-do" approach that inspires others.
• Strong critical thinking and problem-solving skills.
• Proactive, with the ability to anticipate challenges and address them effectively.
• Collaborative and team-oriented with excellent interpersonal skills for cross-departmental collaboration.
• Able to motivate and manage a team of people across a number of development projects.
• Detail-oriented while maintaining a strategic perspective and focus on the bigger picture.
• Willingness to develop in the role and in the company.

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