UK CW Regulatory Affairs Manager

3 weeks ago

City of London Greater London, United Kingdom Proclinical Staffing Full time

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 submission plans and execution of the strategy for one or more products.
* Interfaces with affiliate offices for specific strategies or activities that impact a specific country.
* Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
* Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
* Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within company's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
* Authoring and coordinating responses to questions across assigned products and countries.
* Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
* 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; raises resource constraints
* 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 company products.
* Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.

If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeaur at c.siljeur@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

  • UK CW Regulatory Affairs Manager

    4 days ago

    City of London, United Kingdom Proclinical Staffing Full time

    UK 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 execution of the strategy for one or more products.n* Interfaces with affiliate...

  • UK CW Regulatory Affairs Manager

    1 week ago

    City of London, Greater London, United Kingdom Proclinical Staffing Full time

    UK 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 specific regulatory strategies and providing feedback to internal teams regarding...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    City of London, United Kingdom Proclinical Staffing Full time

    Job 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 submission plans and execution of the strategy for one or more products. * Interfaces...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    City Of London, United Kingdom Proclinical Staffing Full time

    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 submission plans and execution of the strategy for one or more products.* Interfaces with affiliate...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    City Of London, United Kingdom Proclinical Staffing Full time

    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 submission plans and execution of the strategy for one or more products. * Interfaces with affiliate...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    City Of London, United Kingdom Proclinical Staffing Full time

    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 submission plans and execution of the strategy for one or more products. * Interfaces with affiliate...

  • UK CW Regulatory Affairs Manager

    6 hours ago

    City of London, England, Remote, United Kingdom Proclinical Staffing Full time

    UK 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 generation of country specific regulatory strategies and providing feedback to internal teams...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    London, United Kingdom Proclinical Staffing Full time

    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 submission plans and execution of the strategy for one or more products. * Interfaces with affiliate...

  • UK CW Regulatory Affairs Manager

    3 weeks ago

    London, United Kingdom Proclinical Staffing Full time

    UK 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 specific regulatory strategies and providing feedback to internal teams regarding...

  • UK CW Regulatory Affairs Manager

    3 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. Responsibilities: 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...

  • Regulatory Affairs Manager

    1 week ago

    City of London, Greater London, United Kingdom Proclinical Staffing Full time

    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 submission plans and execution of the strategy for one or more products. * Ensuring CMC regional...

  • Regulatory Affairs Manager

    1 week ago

    City of London, Greater London, United Kingdom Proclinical Staffing Full time

    UK 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 specific regulatory strategies and providing feedback to internal teams regarding...

  • Regulatory Affairs AVP

    4 weeks ago

    City of London, Greater London, United Kingdom Michael Page (UK) Full time

    About 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 and avoid fines. This role holder will be one of the approved contacts with the...

  • Ghs/clp Chemical Regulatory Affairs Specialist

    4 weeks ago

    London, United Kingdom VRS Regulatory Full time

    An opportunity to join the Product Stewardship / Regulatory Compliance team at a global chemical business; you will ensure the compliance of globally sold, highly complex mixtures. Key duties will be SDS authoring, classifications, labelling, component compliance checks and providing regulatory advice to the technology, R&D, and customer service...

  • 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

    7 hours 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

    2 days ago

    London, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International are searching for a Regulatory Affairs Manager to join a UK-based pharmaceutical distribution company. As a Regulatory Affairs Manager, you will ensure compliance with all regulations and laws governing the parallel import of medicines. Key responsibilities as the Regulatory Affairs Manager: Preparing and submitting regulatory...

  • Regulatory Affairs Manager

    2 days ago

    London, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    Walker Cole International are searching for a Regulatory Affairs Manager to join a UK-based pharmaceutical distribution company. As a Regulatory Affairs Manager, you will ensure compliance with all regulations and laws governing the parallel import of medicines. Key responsibilities as the Regulatory Affairs Manager: Preparing and submitting regulatory...

  • Regulatory Affairs Manager

    7 hours ago

    Uxbridge, Greater London, United Kingdom CK Group- Science, Clinical and Technical Full time €46

    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...

  • Regulatory Affairs Manager

    4 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...