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Regulatory Affairs Manager - CMC [Biotech]
Description✓PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national Biotech client based in Uxbridge with hybrid work arrangements.
✓This is an initial 6 month contract with strong possibility of extension thereafter
✓This is a hybrid role on a team that is more remote based
✓However, the candidate will need to be able to attend the office in Uxbridge as/when required
✓This role will support one or more products from a regional regulatory perspective
✓Role:
✓• 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 the Amgen 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 Amgen'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 Amgen products.
✓• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
✓Requirements:
✓• 5-8 years relevant experience in regulatory affairs in pharma or biotech
✓• Experience in regulatory affairs strategy development, management and execution
✓• Submissions experience
✓• Ability to work independently and manage submissions independently
✓• Global CMC regulatory experience
✓Interested candidates should submit an updated CV.
✓Please click the link below to apply, or alternatively send an up to date CV to [email protected]
✓***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
✓Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application
✓You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you
✓You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy
✓Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert Show more →
✓This is an initial 6 month contract with strong possibility of extension thereafter
✓This is a hybrid role on a team that is more remote based
✓However, the candidate will need to be able to attend the office in Uxbridge as/when required
✓This role will support one or more products from a regional regulatory perspective
✓Role:
✓• 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 the Amgen 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 Amgen'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 Amgen products.
✓• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
✓Requirements:
✓• 5-8 years relevant experience in regulatory affairs in pharma or biotech
✓• Experience in regulatory affairs strategy development, management and execution
✓• Submissions experience
✓• Ability to work independently and manage submissions independently
✓• Global CMC regulatory experience
✓Interested candidates should submit an updated CV.
✓Please click the link below to apply, or alternatively send an up to date CV to [email protected]
✓***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
✓Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application
✓You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you
✓You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy
✓Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert Show more →