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.
Responsibilities
* 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.
Qualifications
* 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.
Benefits
Our core values of Respect, Reliability, Collaboration and Excellence shape every aspect of our work and our interactions with all our stakeholders. We seek individuals who are respectful, considerate and honest, value diversity and show integrity in their daily work. Our culture thrives on reliability, ensuring we consistently deliver on our promises and meet the expectations of our stakeholders through operational excellence. We believe in the power of collaboration, fostering an agile environment through teamwork and active listening. Our relentless pursuit of excellence drives us to deliver high-quality products and services, while maintaining a supportive and inclusive atmosphere where every team member is recognised and valued. Join us to be part of a community that is committed to mutual success and high standards.
Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com.
#J-18808-Ljbffr