Regulatory Manager
4 weeks ago
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.
As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.
Primary Tasks & Responsibilities:
Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports.
Assess change controls and provide regulatory assessments of quality changes in production and quality control.
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions.
Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
Experience and Knowledge Requirements:
University-level education, preferably in Life Sciences, or equivalent by experience.
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
Strong understanding of CMC and post-approval regulatory requirements.
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
Knowledge of biological processes.
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles.
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
Team spirit, flexibility, accountability, and organizational skills.
Fluent in English (written and spoken). French, Italian and German would be a strong plus.
-
Regulatory Manager
2 weeks ago
Uxbridge, United Kingdom Parexel Full timeAre you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.As the CMC Regulatory Manager, you will play a vital role...
-
Regulatory Affairs Manager
1 week ago
Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full timeCK 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
1 week ago
Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full timeCK 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 CK Group Full timeCK 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, United Kingdom PE Global Full timePE 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.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...
-
Regulatory Affairs Manager
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 day ago
Uxbridge, United Kingdom Park Street People Full timeJob DescriptionAn 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...
-
Regulatory Affairs Manager
7 days ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
1 week ago
Uxbridge, United Kingdom Park Street People Full timeAn 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
5 days ago
Uxbridge, United Kingdom PE Global Full timePE 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.In order to make an application, simply read through the following job description and make sure to attach relevant documents.Responsibilities of the role: Advising the GRT on regional...
-
Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom PE Global Full timePE 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.Responsibilities of the role: Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with...
-
Regulatory Affairs Manager
1 day ago
Uxbridge, United Kingdom PE Global Full timeJob DescriptionPE 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.Responsibilities of the role: Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in...
-
Regulatory Affairs Manager
5 days ago
Uxbridge, United Kingdom PE Global Full timePE 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.Responsibilities of the role: Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with...
-
Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom PE Global Full timePE 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.Responsibilities of the role: Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with...
-
Regulatory Affairs Manager
5 days ago
Uxbridge, United Kingdom PE Global Full timePE 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.Responsibilities of the role: Advising the GRT on regional considerations in developing strategyEnsuring the regional needs are well defined and implemented in collaboration with...
-
Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom PE Global Full timePE 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. Responsibilities of the role: Advising the GRT on regional considerations in developing strategy Ensuring the regional needs are well defined and implemented in collaboration with...