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Park Street People
UxbridgeUxbridgeEnglandUnited Kingdom
Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their
Job Source: Park Street PeoplePark Street People
Uxbridge
Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their
Job Source: Park Street PeopleCpl Life Sciences
UxbridgeUxbridgeEnglandUnited Kingdom
Job Title: Regulatory Affairs CMC Manager Job Type: 6-Month Contract (inside IR35) Location: Uxbridge or Cambridge – 1 day on-site per month Rate: £45 to £55 per hour (PAYE) An exciting opportunity to join a leading global pharmaceutical company on a 6-month basis and sit within the Regulatory CMC team supporting global submissions. This role will
Job Source: Cpl Life SciencesProclinical Staffing
LeedsLeedsWest YorkshireUnited 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 com
Job Source: Proclinical StaffingProclinical Staffing
LeedsLeedsEnglandUnited 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 comme
Job Source: Proclinical StaffingCk Group
UxbridgeUxbridgeGreat LondonUnited Kingdom
CK Group are recruiting for a Regulatory Affairs Manager CMC 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
Job Source: Ck GroupPark Street People
UxbridgeUxbridgeGreat LondonUnited Kingdom
Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Manager to join their team in Uxbridge on a temporary contract. This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their
Job Source: Park Street PeoplePharma Partners Recruitment Ltd
CambridgeCambridgeCambridgeshireUnited Kingdom
Job title: Senior Regulatory Affairs Manager CMC A growing Biotech in Cambridge with multiple Phase 3 assets are seeking a Senior Regulatory Affairs Manager CMC. The role will be responsible for the development, execution and tracking of regulatory CMC and medical device activities. Candidates must have protein experience in addition to medical d
Job Source: Pharma Partners Recruitment LtdLeeds
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 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
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