Regulatory Affairs Manager UK and Ireland

The Consumer Health UK & Ireland Regulatory team provides guidance and advice to the UK and Ireland Businesses and International colleagues on regulatory issues and risks. The strategy is for the overall portfolio including new and existing marketing authorisations for the UK, Ireland and Malta and products in other categories (cosmetics, medical devices and food supplements). Major Tasks - Full regulatory management of the assigned products and / or portfolio comprising e.g. of medicinal products, medical devices, food supplements and cosmetics (including but not limited to: maintenance of existing licenses, registrations, new launches and product information according to statutory requirements) - Draft/Change management of SmPCs, leaflets and labels and overseeing the internal approval, including submission to and approval by local authorities/associations where required. - Evaluation of marketability requests incl advice on opportunities and risks, regulatory go to market strategies, delineation, classification and labeling - Management of all regulatory databases that hold information regarding production, quality, and statutory texts on our active product, which are key to compliance. - Maintenance of medicine dossiers, medical device technical files, food supplement and cosmetic documentation of agreed portfolio according to statutory requirements. - Writing of country specific documents - Liaison with external stakeholders such as Authorities (incl MHRA, DEFRA and other competent authorities) and associations (incl PAGB and other competent associations), as well as internal stakeholders as global and regional Regulatory Affairs, local commercial, Medical, PV and Quality department, together with prompt professional responses to questions. - Support the line manager on development, review, update and implementing local best practice documents. - Ensure compliance with all relevant codes of practice (internally and externally) - Understanding and communication with internal parties the impact of regulatory information and intelligence relevant to the CH business as well as advising the local business on portfolio related issues - Evaluation, preparation, communication, and implementation of changes in the regulatory environment - Introduce new products to the market by contributing to the development process; proposing regulatory strategies for local and global products, and advising on data requirements where UK is target market for global projects - Supporting stakeholders on development, planning and implementation of business-initiatives by pro-active communication, benefit/risk evaluation, development and presentation of regulatory options, time and cost management and coordination of multiple projects in parallel - Liaison with Authorities (incl MHRA, DEFRA and other competent authorities), associations (incl PAGB and other competent associations), global and regional Regulatory Affairs, local Medical, PV and Quality department, together with prompt professional responses to questions. - Monitoring regulatory landscape development and ensure staying current on any updates to ensure implementation, mitigation and compliance.

• Master's degree in Life Sciences or equivalent scientific degree
• Knowledge of national regulatory-relevant legislation with regards to medicinal products.
• Knowledge with regards to medical devices, food supplements and/or cosmetics is desirable.
• Professional fluency in English (verbal and written)
• Ability to analyze, organize and plan effectively with good communications, Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
  
  At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice., "At Bayer, sustainability is ingrained in our mission 'Health for all, hunger for none', driving our commitment to healthcare and agricultural innovation. We prioritise reducing our environmental footprint, enhancing our social impact, and ensuring sustainable business practices. As part of our team, you'll have opportunities to contribute to various initiatives such as achieving climate neutrality across our facilities by 2030, to improving access to healthcare and nutrition to 100 million underserved people worldwide by 2030. Join us and be part of a culture that values innovation and empowers change, as we strive to shape a healthier, more sustainable, and inclusive world."
  
  Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme
• State of the art offices
• International career possibilities
• Flexible and and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.