Regulatory Lead - Established Products
hace 11 horas
Lyon
Regulatory Lead – Established Products Regulatory Affairs Director for Established Products ensures compliance with regional and global regulatory requirements for existing and newly acquired established products, develops and implements regulatory strategies, leads interactions with regulatory agencies and manages a regulatory team. Drives strategic planning based on European or UK regulatory guidelines for all Therapeutic Areas in the company. If you are keen to join a patient centric, high-growth company, then read on and apply today! What You Will Do • Develop and implement regional and global regulatory strategies for established products, • Lead and manage interactions with regulatory authorities, • Collaborate with Commercial, Pharmacovigilance for clinical, safety variations and geographic expansion, • Accountable for compliance by adhering to internal processes and external regional regulatory requirements, • Define the strategy to address regulatory changes in global markets and share knowledge, • Lead and coach Regulatory Professionals: make feedback to develop team members, define clear objectives for the team in alignment with company goals, make responsible decisions to drive performance What We Do Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations. Everything at Essential Pharma is driven by the fact that every patient matters. We are focused on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland. We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for the treatment of high-risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments. What You Will Bring Qualifications • Advanced degree in life sciences, • In depth knowledge of European, and ROW regulatory environment, • Regulatory expertise of life cycle management including maintenance of drugs licenses in EU or UK Experience • Must have significant experience of managing lifecycle regulatory activities for established products including new therapeutic indication registration and safety variations impacting SmPC and Package Leaflet, • Prior hands-on experience of marketing authorisation transfer and leading technology transfer in EU or UK, • Proven hands-on experience with EU or UK regulatory procedures, especially MRP/DCP/CP and NP, • Previous demonstration of working effectively with Manufacturing, Science & Technology team (MSAT) is desirable, • Experienced in working in a matrix environment Core Competencies • Excellent oral and written communication in English language, • Proficient in Microsoft Word, Excel, PowerPoint, • Ability to think strategically within in fast paced environment, • Think strategically and critically evaluate risk to regulatory activities, • Strong agile thinker who can adapt to situations of high-speed change, • Problem solver who can work through complex issues, • Demonstrate a growth mindset and able to coach team members, • Must demonstrate integrity and high ethical standards, • Demonstrates a willingness to achieve goals together and respect the view of others, • Well versed in CMC and clinical variation classifications and submission requirements What To Expect • At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us, • Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious, • This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success, • We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives, • We have an unwavering dedication to employee growth and development
