Director of Policy and Regulatory Affairs

2 weeks ago

Uxbridge Greater London, United Kingdom PE Global Full time

PE Global is recruiting for a UK regulatory affairs manager for our leading pharmaceutical client in Uxbridge on an initial 12-month hybrid contract.
Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for one or more products.
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
Provides guidance for regulatory assessments of change control requests
Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; Gathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activities
Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products.
Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.

An extended knowledge of UK regulatory affairs.
Previous experience within a regulatory affairs environment.
CMC regulatory affairs experience.

  • Director of Policy and Regulatory Affairs

    4 weeks ago

    Uxbridge, Greater London, United Kingdom PE Global Full time

    PE Global is recruiting a Regulatory Affairs Manager (CTA) for our multinational pharmaceutical client based in Uxbridge. The role is hybrid and an initial 12-month contract. May participate as a member of: Global Regulatory Team (GRT) Global Development Team (GDT) Clinical Study Team (CST) Label Working Group (LWG) Regional Teams (e.g. Act as a contact...

  • Senior Manager/Director of Regulatory Affairs

    3 weeks ago

    Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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 Manager/Director of Regulatory Affairs

    7 days ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35) Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global Regulatory Team (GRT), you'll develop and execute...

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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 Manager/Director of Regulatory Affairs

    4 weeks ago

    Uxbridge, Greater London, United Kingdom Park Street People Full time

    An 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...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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...

  • Director of Policy and Regulatory Affairs

    5 days ago

    London, United Kingdom ACHIEVA Group Limited Full time

    Regulatory Affairs Manager – 12 month contract (inside IR35) ++ Within this role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions. Ensure...

  • Director of Policy and Regulatory Affairs

    3 weeks ago

    London, United Kingdom ACHIEVA Group Limited Full time

    Regulatory Affairs Manager – 12 month contract (inside IR35) ++ Within this role you will support one or more products from a regional regulatory perspective. As a member of the Global Regulatory Team, you will achieve the desired labelling by developing and executing regional regulatory strategies and managing effective agency interactions. Ensure...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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 therapeutics....

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, London (Greater), Uxbridge, London (Greater), London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...

  • Regulatory Affairs Manager

    7 days ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35) Duration: 12 months (Extention possible) Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35) Duration: 12 months (Extention possible) Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the...

  • Regulatory Affairs Manager

    5 days ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time €40 - €55

    Regulatory Affairs Manager (Inside IR35) You can get further details about the nature of this opening, and what is expected from applicants, by reading the below. Duration: 12 months (Extention possible) Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Job Description Regulatory Affairs Manager (Inside IR35) Duration: 12 months (Extention possible) Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a...

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, Greater London, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35) Duration: 12 months (Extention possible) Location: Uxbridge, 3 days on-site per week Hourly Rate: £40-£55 per hour dependant on experience. Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the...

  • Regulatory Affairs Manager

    4 weeks ago

    Uxbridge, Greater London, United Kingdom Park Street People Full time

    An 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...

  • Regulatory Affairs Manager

    3 weeks ago

    Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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 therapeutics....

  • Regulatory Affairs Manager

    5 days ago

    Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time

    CK 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 therapeutics....

  • Regulatory Affairs Manager

    1 week ago

    Uxbridge, United Kingdom i-Pharm Consulting Full time

    Regulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...