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Proclinical Staffing
Leeds
Job Description Regulatory Affairs CMC Manager - Remote - Contract Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position. Primary Responsibilities: This role involves working closely with regulatory CMC and cross-functional teams to ensure the success
Job Source: Proclinical StaffingX4 Life Sciences
West yorkshire, England, United Kingdom
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, su
Job Source: X4 Life SciencesSurgical Innovations Ltd
Leeds
Job Description About us For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field. Our success is our people and we currently employ over 100 staff from our
Job Source: Surgical Innovations LtdSurgical Innovations Ltd
Leeds, England, United Kingdom
About us For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field. Our success is our people and we currently employ over 100 staff from our head office in Leed
Job Source: Surgical Innovations LtdHW People Ltd
Leeds
HW People have been exclusively retained by a fast growing, Private Equity backed professional services client who are looking to appoint a Regulatory Reporting Accountant as part of their strategic goals. Reporting into the Group Finance Manager you will play a pivotal role in ensuring compliance with UK regulatory prudential reporting requiremen
Job Source: HW People LtdBrightwork Ltd
Leeds
BaxMed – Quality Management Systems 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
Job Source: Brightwork LtdX4 Group Ltd
West Yorkshire
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, su
Job Source: X4 Group LtdTemplarfox Consultancy Ltd
Keighley
Regulatory Compliance Associate I am recruiting on a permanent basis in the Yorkshire region for a Regulatory Compliance Associate to work within a healthcare business. Responding to market opportunity and business requirements within online and regulated sectors. You will be responsible for: o Responsible for delivery of projects within regulato
Job Source: Templarfox Consultancy LtdLeeds, England, United Kingdom
Regulatory Affairs CMC Manager - Remote - Contract
Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.
Primary Responsibilities:
This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans.
Skills & Requirements:
Knowledge of regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.
Strong project management skills.
Excellent communication and collaboration skills.
Ability to identify issues and develop risk mitigation strategies.
The Regulatory Affairs CMC Manager will:
Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
Manage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions, ensuring high quality and compliance with regulations and guidelines.
Collaborate with U.S. and UK teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals.
Participate in cross-functional project teams as a regulatory CMC representative, ensuring consistent communication within the department and with other functional areas.
Proactively identify issues and suggest appropriate strategies to mitigate risks.
Assist in the preparation for interactions with global regulatory authorities.
If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at [email protected] .
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.
Regulatory Affairs CMC Manager jobs in Leeds, England, United Kingdom
ⓘ There was an unexpected error processing your request.
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