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 Junior Manager
At Bayer, we are committed to driving innovation and excellence in healthcare and agriculture. As a global leader, we recognize that our success is built on the diverse talents and expertise of our employees. We are currently seeking a dedicated and detail-oriented professional for the role of Regulatory Affairs Junior Manager to manage the Regulatory Life Cycle of our local and cluster portfolio across the UK, Ireland, Malta, and the EU North markets (Benelux & Nordic).
In this key position, you will be responsible for ensuring compliance with regulatory obligations for a range of products, including cosmetics, medical devices, and food supplements. You will play a vital role in the overall management and technical support of regulatory databases, ensuring that our portfolio meets all necessary compliance requirements. Your expertise will be essential in preparing and implementing artworks according to relevant ordinances and advising local business units on regulatory aspects and the impact of proposed changes.
Join us in shaping the future of health and agriculture while making a meaningful impact through your regulatory expertise.
YOUR TASKS AND RESPONSIBILITIES
1. Maintenance of medicine dossiers, medical device technical files, food supplement and cosmetic documentation of agreed portfolio according to statutory requirements.
2. 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, and implementation where required.
3. Ensure compliance with all relevant codes of practice (internally and externally)
4. Ensure appropriate timetabling/tracking of submission dates and relevant data for PSURs
5. Management of changes and/or coordination/distribution of lifecycle changes across EUN as appropriate to ensure compliance across the cluster
6. Management of all regulatory databases that hold information regarding production, quality, and statutory texts on our active products.
7. Liaison with Authorities (incl MHRA, DEFRA and other competent authorities), associations (incl PAGB and other competent associations), global and regional Regulatory Affairs, together with prompt professional responses to questions.
8. Monitoring regulatory landscape development and ensure staying current on any updates to ensure implementation, mitigation and compliance.
WHO YOU ARE
9. Scientific degree (i.e. PhD, PharmD etc.) or equivalent
10. Experience: Desirable but not mandatory: Knowledge of national/EU regulatory-relevant legislation with regards to medicinal products. Knowledge with regards to medical devices, food supplements and/or cosmetics Experience in working cross-functionally and with teams (virtually and in person)
11. Competencies: Strategic Thinking, Consumer & Customer Focus, Business Acumen, Actively Participate, Team Player, Taking Risks-Building Contingencies Communication Skills: Professional fluency in English (verbal and written) Communication Skills: Ability to analyze, organize and plan effectively with good communications, able to explain complex scientific topics in an understandable way and clearly associate with business case
WHAT BAYER OFFERS YOU
As a modern employer, we take care of our employees and help them find a balance between career development opportunities and personal life planning. We offer our employees a wide range of career prospects, a modern working environment and competitive compensation. Bayer employees benefit from great employment conditions, such as:
12. Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
13. 28 days annual leave plus bank holidays
14. Private Healthcare, generous pension scheme and Life Insurance
15. Wellness programs and support
16. Employee discount scheme
17. International career possibilities
18. Flexible and Hybrid working
19. Help with home office equipment
20. Volunteering days
21. Support for professional growth in a wide range of learning and development opportunities
22. We welcome and embrace diversity providing an inclusive working environment
In this role you will start with a year contract with view on a permanent employment.
The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.
23. #LI-UK
24. #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 .
“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.”
INTERESTED IN THIS VACANCY?
Are you looking for a new challenge? Apply online by sending us your resume and cover letter (in 1 document). Do you have a question, or do you want to learn more about the position? You can always contact Klazien Flapper via klazien.flapper.ext@bayer.com.
What can you expect? The application process consists of a personality questionnaire and an interview with the recruiter and hiring manager.