Regulatory Affairs Manager UK and Ireland /EU North

Bayer AG; Reading; Hybrid; GBP 45,000 - 75,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Manager for the UK and Ireland. In this pivotal role, you will oversee the regulatory management of a diverse portfolio, including medicinal products, medical devices, and cosmetics. Your expertise will guide compliance with national and EU regulations, while your analytical skills will help identify efficiencies and opportunities within the regulatory landscape. This innovative firm offers a competitive compensation package, flexible working arrangements, and a commitment to professional growth. If you are passionate about regulatory affairs and thrive in a dynamic environment, this opportunity is perfect for you.

Benefits

Competitive compensation package

28 days annual leave plus bank holidays

Private Healthcare

Generous pension scheme

Life Insurance

Wellness programs

Flexible working

Support for professional growth

Help with home office equipment

Inclusive working environment

Qualifications

• Master's degree in Life Sciences or equivalent required.
• Knowledge of EU regulatory legislation for medicinal products is essential.

Responsibilities

• Manage regulatory compliance for medicinal products, medical devices, and cosmetics.
• Liaise with authorities and internal stakeholders on regulatory matters.

Skills

Regulatory Management

Legislation Knowledge

Communication Skills

Analytical Skills

Planning and Organization

Education

Master’s degree in Life Sciences

Equivalent scientific degree

Tools

Regulatory Databases

Job description

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

1. 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).
2. Ensure compliance with all relevant codes of practice (internally and externally).
3. Evaluation of marketability requests including 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.
4. Management of changes and/or coordination/distribution of lifecycle changes across EUN as appropriate to ensure compliance across the cluster.
5. 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.
6. Development, review, update and implement local best practice documents.
7. 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.
8. Management of all regulatory databases that hold information regarding production, quality, and statutory texts on our active products.
9. 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.
10. Evaluation, preparation, communication, and implementation of changes in the regulatory environment.
11. 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 degree.
• Knowledge 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.

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 holidays.
• Private Healthcare, generous pension scheme and Life Insurance.
• Wellness programs and support.
• State of the art offices.
• International career possibilities.
• Flexible and Hybrid working.
• Help with home office equipment.
• Support for professional growth in a wide range of learning and development opportunities.
• We welcome and embrace diversity providing an inclusive working environment.