- 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.
- 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.
-
Regulatory Affairs
2 weeks ago
Michael Page (UK) City of London, Greater London, United KingdomOur client is a highly regarded international bank based in their City of London office. · Liaising with the regulator to manage regulatory risk, and implementing new regulations in order to maintain a strong relationship with the regulator and avoid fines. · Liaise with regula ...
-
Regulatory Affairs
3 weeks ago
Page Executive City of London, Greater London, United KingdomOur client is a securities firm and provides a range of execution and clearing services for exchange traded derivatives and OTC derivatives in commodities including base metal contracts on the London Metal Exchange. · Lead and manage the compliance team, ensuring adherence to re ...
-
Regulatory Affairs
3 weeks ago
Michael Page (UK) City of London, Greater London, United KingdomOur client is a securities firm and provides a range of execution and clearing services for exchange traded derivatives and OTC derivatives in commodities including base metal contracts on the London Metal Exchange. Lead and manage the compliance team, ensuring adherence to regul ...
-
Regulatory Affairs AVP
1 week ago
Michael Page (UK) City of London, Greater London, United Kingdom £50,000 - £70,000About Our Client · Our client is a highly regarded international bank based in their City of London office. · Job Description · Liaising with the regulator to manage regulatory risk, and implementing new regulations in order to maintain a strong relationship with the regulator ...
-
Senior Regulatory Affairs
2 weeks ago
Cpl Life Sciences City of London, Greater London, United KingdomJob Title: Senior Regulatory Affairs & PV Manager · Employment Type: Permanent position · Location: East London, 3 days on-site. (Hybrid) · Remuneration: Competitive salary and package · Ready to apply Before you do, make sure to read all the details pertaining to this job in the ...
-
Senior Regulatory Affairs Associate
8 hours ago
Cpl Life Sciences City of London, Greater London, United Kingdom £40,000 - £46,500Job Title: · Increase your chances of an interview by reading the following overview of this role before making an application. · Senior Regulatory Affairs Officer (Maternity Cover) · Location: · North London, UK – (Hybrid) · Remuneration: · £40,000 - £46,500 · Senior Regulatory ...
-
Regulatory Affairs Senior Associate
8 hours ago
Cpl Life Sciences City of London, Greater London, United Kingdom £40,000 - £46,500Senior Regulatory Affairs Officer (Maternity Cover) · North London, UK - (Hybrid) · Senior Regulatory Affairs Officer opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing a ...
-
Senior Regulatory Affairs Officer
1 week ago
Cpl Life Sciences City of London, Greater London, United Kingdom £50,000Job Title: Senior Regulatory Affairs Officer · Do you have the following skills, experience and drive to succeed in this role Find out below. · Employment Type: Permanent · Location: East London, 3 days on-site per week. (Hybrid) · Salary: Up to £50,000 · Senior Regulatory Affair ...
-
Senior Regulatory Affairs Officer
2 weeks ago
Cpl Life Sciences City of London, Greater London, United KingdomJob Title: Senior Regulatory Affairs Officer · Employment Type: Permanent · Location: East London, 3 days on-site per week. (Hybrid) · Salary: Up to £50,000 · Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling ...
-
Director of Policy and Regulatory Affairs
2 weeks ago
Proclinical Staffing City of London, Greater London, United KingdomJob Description UK CW Regulatory Affairs Manager (Inside IR35) · This role will support one or more products from a regional regulatory perspective. · * Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding su ...
-
Proclinical Staffing City of London, Greater London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35) · The following information provides an overview of the skills, qualities, and qualifications needed for this role. · This role will support one or more products from a regional regulatory perspective. · * Responsible for the generat ...
-
Director of Policy and Regulatory Affairs
1 week ago
Proclinical Staffing City of London, Greater London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35)Check below to see if you have what is needed for this opportunity, and if so, make an application asap.This role will support one or more products from a regional regulatory perspective. * Responsible for the generation of country sp ...
-
UK CW Regulatory Affairs Manager
6 days ago
Proclinical Staffing london (city of london), United KingdomUK CW Regulatory Affairs Manager (Inside IR35) · This role will support one or more products from a regional regulatory perspective. · * Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans an ...
-
UK CW Regulatory Affairs Manager
1 week ago
Proclinical Staffing City of London, United KingdomJob DescriptionUK CW Regulatory Affairs Manager (Inside IR35) · This role will support one or more products from a regional regulatory perspective. · * Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding subm ...
-
Regulatory Affairs Manager ASIC/MAS
1 day ago
Control Now City of London, Greater London, United KingdomJob Title: Regulatory Affairs Manager (ASIC/MAS) · Take the next step in your career now, scroll down to read the full role description and make your application. · Team: Regulatory Affairs · Location: Remote working with offices in London & Sofia · Rate: Competitive, + commissio ...
-
UK CW Regulatory Affairs Manager
18 hours ago
Proclinical Staffing City of London, Greater London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35)Ensure you read the information regarding this opportunity thoroughly before making an role will support one or more products from a regional regulatory perspective. * Responsible for the generation of country specific regulatory stra ...
-
UK CW Regulatory Affairs Manager
1 day ago
Proclinical Staffing City of London, Greater London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35) · The following information provides an overview of the skills, qualities, and qualifications needed for this role. · This role will support one or more products from a regional regulatory perspective. · Responsible for the generatio ...
-
UK CW Regulatory Affairs Manager
1 week ago
Proclinical Staffing City Of London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35) · This role will support one or more products from a regional regulatory perspective. · * Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans an ...
-
UK CW Regulatory Affairs Manager
1 week ago
Proclinical Staffing City of London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35) · This role will support one or more products from a regional regulatory perspective.n* Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and ...
-
UK CW Regulatory Affairs Manager
1 week ago
Proclinical Staffing City of London, Greater London, United KingdomUK CW Regulatory Affairs Manager (Inside IR35)Check below to see if you have what is needed for this opportunity, and if so, make an application asap.This role will support one or more products from a regional regulatory perspective. * Responsible for the generation of country sp ...
Senior Regulatory Affairs - City of London, Greater London, United Kingdom - Cpl Life Sciences
Description
Job Title: Senior Regulatory Affairs & PV Manager
Make your application after reading the following skill and qualification requirements for this position.
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
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
