Senior Regulatory Affairs
3 weeks ago
Job Title: Senior Regulatory Affairs & PV Manager
Employment Type: Permanent position
Location: East London, 3 days on-site. (Hybrid)
Remuneration: Competitive salary and package
Senior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the team and lead the RA and PV Team (4 individuals).
This role will have a main focus on UK and European submissions through MRP, DCP, and National procedures managing over 150 licenses. You will be responsible for managing regulatory submissions, MA Transfers, Initial MAA’s, new registrations, and variations applications.
Responsibilities
- required regulatory processes for UK and European products including submitting submissions through National MRP and DCP.
- develop, and leads regional strategies to maximize regulatory and pharmacovigilance success.
- knowledge of requirements of MA Transfer in EU territories, which includes requirements of notarization and translations.
- a team of 4 to ensure day-to-day activities are carried out in Regulatory and Pharmacovigilance.
- all pre-submission meetings including inputting into scientific advice meetings.
- responsible for all initial/new MAA applications into main EU countries.
- MA approvals ensure product maintenance including submission of national variations or notifications.
- EU and UK product labelling approval and compliance with the MA approval activities.
- interact with the MHRA and any EU UK Regulatory Authority. Ensuring that regulatory processes are completed and products are launched in line with regulatory requirements.
- and implement local procedures and processes to ensure regulatory compliance is met for EU and UK portfolios.
Requirements
- degree or higher in Life Sciences or technical field.
- to 10 years of relevant regulatory experience especially within the UK and European markets. Submitting through MRP, DCP and national procedures.
- strong communicator who is able to navigate through difficult conversations with senior stakeholders.
- team working skills, able to influence to achieve objectives.
This position allows for the right candidate to work for a growing pharmaceutical company and take charge of UK and European submissions. The role will play a pivotal part in the Regulatory Affairs and PV team and ensure all compliance. The role includes some excellent benefits including a generous bonus scheme.
To apply for this role you must have the full right to work in Europe as this employer does not provide sponsorship. For more information please contact lucy.kirkaldy@cpl.com
-
Regulatory affairs senior
2 weeks ago
London, United Kingdom Compliance Professionals Full timeOur client is a successful banking firm with a strong global presence, offering a comprehensive range of services across corporate and investment banking activities. Act as a subject matter expert in Regulatory Affairs. Maintain an effective, professional and proactive relationship with UK regulators and assist the Local Compliance Officers in dealing...
-
Senior Regulatory Affairs
3 weeks ago
London, Greater London, United Kingdom Cpl Full timeJob Title: Senior Regulatory Affairs & PV Manager Employment Type: Permanent positionLocation: East London, 3 days on site. (Hybrid) Remuneration: Competitive salary and packageSenior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The...
-
Regulatory Affairs Consultant
4 weeks ago
London, United Kingdom Brightwork Ltd Full timeBaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...
-
Regulatory Affairs Consultant
4 weeks ago
London, United Kingdom Brightwork Ltd Full timeBaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...
-
Senior Manager/Director of Regulatory Affairs
2 weeks ago
Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This...
-
Senior Regulatory Affairs
3 weeks ago
Greater London, United Kingdom Cpl Life Sciences Full timeJob Title: Senior Regulatory Affairs & PV ManagerEmployment Type: Permanent positionLocation: East London, 3 days on-site. (Hybrid)Remuneration: Competitive salary and packageSenior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business...
-
Senior Regulatory Affairs
3 weeks ago
Greater London, United Kingdom Cpl Life Sciences Full timeJob Title: Senior Regulatory Affairs & PV ManagerEmployment Type: Permanent positionLocation: East London, 3 days on-site. (Hybrid)Remuneration: Competitive salary and packageSenior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business...
-
Senior Regulatory Affairs
3 weeks ago
Greater London, United Kingdom Cpl Life Sciences Full timeJob Title: Senior Regulatory Affairs & PV ManagerEmployment Type: Permanent positionLocation: East London, 3 days on-site. (Hybrid)Remuneration: Competitive salary and packageSenior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The business...
-
Senior Regulatory Affairs
3 weeks ago
Greater London, United Kingdom Cpl Life Sciences Full timeJob Title: Senior Regulatory Affairs & PV Manager Employment Type: Permanent position Location: East London, 3 days on-site. (Hybrid) Remuneration: Competitive salary and package Senior Regulatory Affairs & PV Manager opportunity working for a growing pharmaceutical company specialising in medicinal, non-medicinal, medical devices, and OTC products. The...
-
Sds Author
1 month ago
London, United Kingdom VRS Regulatory Full timeWe are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...
-
Ad-Hoc Senior Regulatory Affairs Consultant
4 weeks ago
London, United Kingdom Brightwork Ltd Full timeBaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...
-
Ad-Hoc Senior Regulatory Affairs Consultant
4 weeks ago
London, United Kingdom Brightwork Ltd Full timeBaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...
-
Interim Senior Regulatory Affairs Associate
3 days ago
London, United Kingdom Silven Recruitment Ltd Full timeSenior Regulatory Affairs Associate (Interim - 1 Year) - Remote Are you a detail-oriented Senior Regulatory Affairs Associate with a comprehensive understanding of regulations surrounding supplements and nutrition claims? This 12-month interim role offers a high degree of autonomy and the flexibility of remote work at a leading pharmaceutical company. About...
-
Senior Regulatory Affairs Associate
1 day ago
London, United Kingdom Pharma Partners Recruitment Ltd Full timeJob Description Job title: Senior Regulatory Affairs Associate A food and nutrition business in London are seeking a Senior Regulatory Affairs Associate to join their team. In this role you will play a pivotal role in a new project focused on developing a comprehensive product claims database Responsibilities: closely with multidisciplinary teams, to...
-
Senior Regulatory Affairs Associate
1 week ago
London, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs Associate A food and nutrition business in London are seeking a Senior Regulatory Affairs Associate to join their team. In this role you will play a pivotal role in a new project focused on developing a comprehensive product claims database Responsibilities: closely with multidisciplinary teams, to ensure that the...
-
Regulatory Affairs Manager
2 weeks ago
Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human...
-
Senior Regulatory Affairs Associate
1 week ago
London, United Kingdom Pharma Partners Recruitment Ltd Full timeJob title: Senior Regulatory Affairs AssociateA food and nutrition business in London are seeking a Senior Regulatory Affairs Associate to join their team. In this role you will play a pivotal role in a new project focused on developing a comprehensive product claims databaseResponsibilities:closely with multidisciplinary teams, to ensure that the...
-
Senior Regulatory Affairs Associate
7 days ago
London, United Kingdom Pharma Partners Recruitment Ltd Full timeJob DescriptionJob title: Senior Regulatory Affairs AssociateA food and nutrition business in London are seeking a Senior Regulatory Affairs Associate to join their team. In this role you will play a pivotal role in a new project focused on developing a comprehensive product claims databaseResponsibilities:closely with multidisciplinary teams, to ensure that...
-
Regulatory Affairs Manager
2 weeks ago
Uxbridge, Greater London, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Interim Senior Regulatory Affairs Associate
23 hours ago
London, United Kingdom Silven Recruitment Ltd Full timeSenior Regulatory Affairs Associate (Interim - 1 Year) - RemoteIf you are interested in applying for this job, please make sure you meet the following requirements as listed below.Are you a detail-oriented Senior Regulatory Affairs Associate with a comprehensive understanding of regulations surrounding supplements and nutrition claims?This 12-month interim...