Job Description 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! Job Requirements 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 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 Job Responsibilities 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 Job Benefits Competitive salary We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview £150 towards your home office Healthcare Pension – you contribute 5% and we offer 5%. Life Insurance – lump sum (tax free) death benefit of 4 x basic salary. Enhanced family leave Enhanced sick pay 25 days annual leave Discretionary annual performance bonus 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