STADA UK Thornton & Ross is on an exciting growth journey with more than 700 employees being fully committed to our purpose of Caring for People’s Health as a Trusted Partner. Together we are shaping the future of Thornton & Ross by living our values of Integrity, Entrepreneurship, Agility and One STADA. If you want to work in an open culture where your uniqueness is valued, and have recently graduated, please submit your application. STADA UK Thornton & Ross – Regulatory Affairs Officer Huddersfield | U.K.| Full-time | Permanent We are looking for an experienced and enthusiastic Regulatory Affairs professional to join a dynamic team where you will take ownership of a portfolio of diverse projects, help strengthen ways of working in the team and with business partners and support the development of colleagues within the Regulatory function. Given the broad portfolio of products at STADA, you will have the opportunity to work on OTCs, generics, biosimilar and orphan medicines. The role will mainly relate to new registrations, however there will be some post-launch and compliance activities to support. How You Will Make An Impact Work with key partners across the business as the Regulatory lead on high profile licenced medicines projects including NPD and key maintenance initiatives. Support new and existing product maintenance by preparing comprehensive regulatory strategies, aligning stakeholders, and delivering projects in line with agreed business plans. Engaging with regulatory authorities and trade associations. Performing dossier review/gap-analysis in support of product acquisition. Preparing and submitting dossiers to achieve timely authority approvals. Provide Regulatory support on our Biosimilars and Speciality product portfolio. What We Are Looking For A relevant Life Sciences Bachelor’s degree at grade 2:1 or above. Several years solid medicines Regulatory work experience including managing the registration and life-cycle management of product files. Experience with MAAs and variation procedures for the UK/EU market (national and MR/DC) including eCTD dossier preparation and publishing and submission. Experience with document management systems (e.g. FirstDoc/Docuentum), publishing software (e.g. docuBridge) and licencing databases/submissiom portals e.g. CESP/MHRA Well developed understanding of the commercial drivers and regulatory strategies and registration routes. Exceptional interpersonal and communication skills, with the ability to engage and quickly develop rapport with others. Robust organizational and project management skills, adept at multitasking and prioritizing effectively to meet deadlines. How We Care For You At Thornton & Ross our purpose “Caring for people’s health as a trusted partner” motivates us every day. And what would be a better place than starting with our own employees. Which is why we give much in return: Competitive salary and annual bonus scheme. Salary Sacrifice Pension Scheme offering 6% employer contribution rates. Hybrid working – we spend three days of your choice in the office, with the remaining days working at home. 25 days of annual leave plus bank holidays with the potential to buy up to 5 additional days. On-site subsidised canteen. Health benefits provided through our Medicash Health Cash Plan. Free winter flu jab. Wellbeing support through our Employee Assistance Programme and KYAN Wellbeing – offering free coaching and counselling services for you and your family. Electric Car Scheme through Octopus Energy, plus free on-site EV charging. Cycle to Work Scheme. Enhanced Family Leave. Plus, many more employee benefits & celebration events. STADA Group values and promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology, or sexual orientation. We use the strength of our uniqueness to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation, and the promotion of an inclusive working environment. We are looking forward to your application and welcome applications without a pharmaceutical background.