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.
Regulatory Affairs Manager UK and Ireland /EU North
Regulatory Affairs Manager UK and Ireland /EU North
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 regulatory teams cover 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), as well as to support where required across EU North – UKI, Benelux, Nordics.
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)
- Ensure compliance with all relevant codes of practice (internally and externally)
- Evaluation of marketability requests incl advice on opportunities and risks, regulatory go to market strategies, delineation, classification and labelling Establish a process for oversight and coordination of lifecycle maintenance activities for all portfolios across EU North
- Management of changes and/or coordination/distribution of lifecycle changes across EUN as appropriate to ensure compliance across the cluster
- Seek to identify efficiencies in ways of working as a regulatory team across the cluster with a focus on, but not limited to, lifecycle management
- Development, review, update and implement local best practice documents.
- Writing of country specific local documents including but not limited to drafting/change management of SmPCs, leaflets and labels, including management of internal/external approvals, where required.
- Management of all regulatory databases that hold information regarding production, quality, and statutory texts on our active products.
- 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 including Enterprise/Regional Regulatory Affairs, Local commercial, Medical, PV and Quality
- Evaluation, preparation, communication, and implementation of changes in the regulatory environment
- 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
Who you are?
Master’s degree in Life Sciences or equivalent scientific degreeKnowledge of national/EU 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
Your Application:
Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee.
What we offer
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 holidaysPrivate Healthcare, generous pension scheme and Life InsuranceWellness programs and supportEmployee discount schemeState of the art offices International career possibilitiesFlexible and and Hybrid workingHelp with home office equipmentVolunteering daysSupport for professional growth in a wide range of learning and development opportunitiesWe 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.
#LI-UK
#Hybrid
Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter.
Bayer is committed to providing access and support for all individuals with disabilities and / or long term conditions - during the application process and beyond. Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply please contact HROP_UK@bayer.com.
“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.”
Location:
United Kingdom : Berkshire : Reading
Division:
Consumer Health
Reference Code:
830782