Regulatory Affairs Specialist UK and Ireland
3 weeks ago
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 to ensure 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) is compliant and up-to-date.
Main Responsibilities
- Evaluate and manage the regulatory aspects of assigned products and/or portfolio comprising medicinal products, medical devices, food supplements, and cosmetics.
- Develop and manage SmPCs, leaflets, and labels, and oversee the internal approval process, including submission to and approval by local authorities/associations where required.
- Assess marketability requests, including advice on opportunities and risks, regulatory go-to-market strategies, delineation, classification, and labeling.
- Manage regulatory databases that hold information regarding production, quality, and statutory texts on our active product, ensuring compliance.
- Prepare and maintain medicine dossiers, medical device technical files, food supplement, and cosmetic documentation of agreed portfolio according to statutory requirements.
- Develop country-specific documents.
- Communicate effectively 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 global and regional Regulatory Affairs, local commercial, Medical, PV, and Quality departments.
- Support the line manager in developing, reviewing, updating, and implementing local best practice documents.
- Ensure compliance with all relevant codes of practice, both internally and externally.
- Communicate the impact of regulatory information and intelligence relevant to the CH business to internal parties and advise the local business on portfolio-related issues.
- Evaluate, prepare, communicate, and implement changes in the regulatory environment.
- Contribute to introducing new products to the market by developing regulatory strategies for local and global products and advising on data requirements where the UK is the target market for global projects.
- Support stakeholders in developing, planning, and implementing business initiatives through proactive communication, benefit/risk evaluation, development, and presentation of regulatory options, time and cost management, and coordination of multiple projects in parallel.
- Monitor regulatory landscape development and ensure staying current on updates to ensure implementation, mitigation, and compliance.
Requirements
- Master's degree in Life Sciences or equivalent scientific degree.
- Knowledge of national regulatory-relevant legislation with regards to medicinal products.
- Desirable knowledge of medical devices, food supplements, and/or cosmetics.
- Professional fluency in English (verbal and written).
- Ability to analyze, organize, and plan effectively with good communication skills.
What We Offer
- A competitive compensation package consisting of an attractive base salary and annual bonus.
- 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.
-
Regulatory Affairs Specialist
1 month ago
Reading, Reading, United Kingdom newscientist - Jobboard Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team in Reading, UK. As a key member of our UK & Ireland Regulatory Affairs team, you will play a crucial role in supporting the business units within Sanofi in both the UK & Ireland, through applying for and maintaining a diverse portfolio of...
-
Regulatory Affairs Specialist
23 hours ago
Reading, Reading, United Kingdom Actalent Full timeRegulatory Affairs Manager Role OverviewAt Actalent, we are seeking an experienced Regulatory Affairs Manager to join our dynamic and innovative pharmaceutical company. As a Regulatory Affairs Manager, you will be responsible for providing expert regulatory guidance to our UK organization and managing all regulatory activities across the UK and Ireland.Key...
-
Reading, Reading, United Kingdom Actalent Full timeActalent is seeking a highly skilled Regulatory Affairs Manager to provide expert guidance to our UK organization and manage regulatory activities across the UK and Ireland.Job SummaryThis role involves providing regulatory expertise to the organization, managing regulatory activities for the UK and Ireland, ensuring compliance with UK regulatory processes...
-
Regulatory Affairs Specialist
1 month ago
Reading, Reading, United Kingdom newscientist - Jobboard Full timeRegulatory Affairs Specialist - Promotional Materials ReviewLocation: Reading, UKAbout the roleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for reviewing promotional and non-promotional materials to ensure compliance with relevant legal...
-
Regulatory Affairs Specialist
2 weeks ago
Reading, Reading, United Kingdom CK Group Full timeJob Title: Regulatory Life Cycle Management ScientistCompany: CK GroupWe are seeking an experienced Regulatory Life Cycle Management Scientist to join our team. As a regulatory affairs specialist, you will be responsible for coordinating regulatory life cycle management activities across multiple countries.Coordinate regulatory life cycle management...
-
Regulatory Affairs Specialist
4 weeks ago
Reading, Reading, United Kingdom CK Group Full timeJob Title: Regulatory Life Cycle Management ScientistCompany: CK GroupLocation: ReadingJob Type: ContractDuration: 12 monthsAbout the Role:We are recruiting for a Regulatory Life Cycle Management Scientist to join a global Consumer Healthcare company based in Reading.Key Responsibilities:* Coordinate Regulatory Life Cycle Management activities across...
-
Regulatory Affairs Specialist
3 weeks ago
Reading, Reading, United Kingdom CK Group Full timeJob OpportunityWe are seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team at CK Group, a global Consumer Healthcare company based in Reading. The successful candidate will work on a contract basis for 12 months.About the RoleAs a Regulatory Life Cycle Management Scientist, you will be responsible for coordinating Regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
Reading, Reading, United Kingdom CK Group Full timeJob Title: Regulatory Life Cycle Management ScientistCompany: CK GroupLocation: ReadingJob Type: ContractDuration: 12 monthsAbout the Role:We are seeking a highly skilled Regulatory Life Cycle Management Scientist to join our team at CK Group. As a key member of our global Consumer Healthcare company, you will be responsible for coordinating Regulatory Life...
-
Regulatory Affairs Project Manager
1 month ago
Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full timeRegulatory Affairs Project ManagerA leading pharmaceutical company in the UK is seeking a highly skilled Regulatory Affairs Project Manager to join their team. This is a fantastic opportunity to work on a variety of projects and contribute to the success of the company.The successful candidate will be responsible for managing clinical trial activities with...
-
Senior Regulatory Affairs Specialist
2 weeks ago
Reading, Reading, United Kingdom CK Group Full timeAbout CK GroupWe are recruiting for a highly skilled Regulatory Life Cycle Management Scientist to join our client, a global Consumer Healthcare company based in Reading, on a contract basis for 12 months.The RoleThis is an excellent opportunity for an experienced professional to take ownership of coordinating regulatory life cycle management activities...
-
Regulatory Affairs Specialist
1 month ago
Reading, Reading, United Kingdom ICON plc Full timeAt ICON plc, we're seeking a highly skilled Study Start Up Associate II to join our dynamic team. As a key member of our team, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.Key Responsibilities:Prepare and...
-
Regulatory Affairs Policy Strategist
4 weeks ago
Reading, Reading, United Kingdom Bayer Full timeAt Bayer, we're driven to solve the world's toughest challenges and strive for a world where health for all and hunger for none is no longer a dream, but a real possibility.Regulatory Affairs Policy StrategistThe Regulatory Policy Strategist within the Regulatory Policy and Intelligence team is responsible for maximizing external advocacy efforts through...
-
Regulatory Affairs Specialist Healthcare
3 weeks ago
Reading, Reading, United Kingdom Bayer Full timeAt Bayer, we're committed to creating a healthier world.We're seeking a highly skilled Regulatory Affairs Manager to join our team in a role that will drive the life cycle management of medical devices, drug-device combinations, and digital health products.As a key member of our regulatory intelligence cluster, you will prepare and maintain medical device...
-
Regulatory Affairs Specialist
2 days ago
Reading, Reading, United Kingdom Tower Cold Chain Solutions Full timeAbout the Role:Tower Cold Chain Solutions is seeking an experienced Quality Assurance and Regulatory Affairs Manager to join our team. As a key member of our operations team, you will be responsible for ensuring the quality and compliance of our products and services.In this role, you will work closely with our Global Head of Operations and CEO to deliver a...
-
Regulatory Affairs Policy Strategist
4 weeks ago
Reading, Reading, United Kingdom Bayer Full timeAt Bayer, we're driven to solve the world's toughest challenges and strive for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility.Regulatory Affairs Policy StrategistThe Regulatory Policy Strategist within the Regulatory Policy and Intelligence team is responsible for maximizing external advocacy efforts through...
-
Compliance and Regulatory Affairs Specialist
5 days ago
Reading, Reading, United Kingdom Thames Water Full timeAbout the RoleAs a key member of our Strategy and External Affairs team, you will play a critical role in shaping and embedding strategies that deliver exceptional results for our customers, communities, and the environment.We are responsible for managing relationships with key stakeholders, including regulators and policy makers, to build trust and enable...
-
Global Regulatory Affairs Manager
2 weeks ago
Reading, Reading, United Kingdom Bayer AG Full timeRegulatory Affairs Policy RoleThe Senior Manager Inclusion Health Policy role plays a critical part in ensuring the company can effectively navigate and shape the external regulatory landscape to better enable self-care across the diverse portfolio that spans OTC medicines, medical devices, cosmetics, and food supplements.Key ResponsibilitiesLead, develop,...
-
Regulatory Affairs Project Manager
4 weeks ago
Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full timeJob DescriptionPharma Partners Recruitment Ltd is seeking a Regulatory Affairs Project Manager to join their team in the UK/IE affiliate role. This position will work across an Oncology portfolio, managing lifecycle activities and clinical trials with the MHRA.Key Responsibilities:Interface with Health Authorities and serve as a liaison for regulatory...
-
Regulatory Affairs Policy Strategist
4 weeks ago
Reading, Reading, United Kingdom Bayer AG Full timeRegulatory Policy Strategist Job Description**About the Role**At Bayer, we're seeking a highly skilled Regulatory Policy Strategist to join our Regulatory Policy and Intelligence team. As a key member of our team, you will be responsible for maximizing our external advocacy efforts through setting key regulatory policy priorities and ensuring aligned...
-
Regulatory Affairs Project Manager
4 weeks ago
Reading, Reading, United Kingdom Pharma Partners Recruitment Ltd Full timeRegulatory Affairs Project Manager - Oncology PortfolioA leading pharmaceutical company in Berkshire is seeking a Regulatory Affairs Project Manager to join their team. This role will involve working across an Oncology portfolio, managing lifecycle activities and clinical trials with the MHRA.The successful candidate will have experience in Regulatory...