Senior Manager/Director of Regulatory Affairs
2 weeks ago
PE Global is currently recruiting for a Regulatory Affairs CMC Manager for a contract role with a leading multinational Biotech client based in London – Fully remote within the UK. Regulatory CMC support for post-approval submissions for commercial products, predominantly biotechnology products and new international MAA filings predominantly in EMEA region. regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
compilation and project management of all necessary documentation for commercial regulatory CMC submissions and response to questions. Ensure submissions are high quality; the content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure and marketing of chemical drugs, biologics or gene therapies.
in cross-functional project teams as a regulatory CMC representative for project specific discussions. identifying issues and suggesting appropriate strategies to mitigate risks.
in the preparation for interactions with global regulatory authorities
of generating global regulatory strategy documents.
ability to lead SME team of authors to generate variation/supplement content enabling Right First-Time approvals.
knowledge of regulatory legislation and CMC guidance in EU, US and ICH markets.
knowledge of regulatory submissions for biotech products.
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(Senior) Director Regulatory Affairs CMC
24 hours ago
United Kingdom Autolus Ltd Full timeVacancy for (Senior) Director Regulatory Affairs CMC Location: United Kingdom Job Summary Role Summary An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene...
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....
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United Kingdom Meet Full timeAssociate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....
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United Kingdom Autolus Ltd Full timeVacancy for Senior Director/ Executive Director Regulatory Affairs Lead - Autoimmune Location: UK/EU/US Job Summary Role Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Global Regulatory Affairs Lead (Senior Director/Executive Director) for AutoImmune to join the Autolus team to expand their...
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Regulatory Affairs Specialist
10 hours ago
United Kingdom Meet Recruitment Limited Full timeRegulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...
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Senior Manager/Director of Regulatory Affairs
3 weeks ago
United Kingdom MERJE Full timeThis is an excellent opportunity to join a leading insurance company as a Regulatory Affairs Manager. The successful candidate will be responsible for providing guidance, aid and advice to the company's UK businesses and compliance colleagues on technical compliance matters and regulatory developments. Establishing and maintaining strong stakeholder...
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Senior Regulatory Affairs Officer
2 weeks ago
United Kingdom Hyper Recruitment Solutions Full timeWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. Your...
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Senior Regulatory Affairs Officer
2 weeks ago
United Kingdom Hyper Recruitment Solutions Full timeWe are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. Your...
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Senior Regulatory Affairs Associate
7 days ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...
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Senior Regulatory Affairs Associate
1 week ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...
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Senior Regulatory Affairs Associate
1 week ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...
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Senior Regulatory Affairs Associate
1 week ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs AssociateLocation: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a Senior...
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Senior Regulatory Affairs Associate
1 week ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...
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Senior Regulatory Affairs Associate
1 week ago
United Kingdom Meet Full timeJob Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...
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Senior Regulatory Affairs Associate
6 days ago
United Kingdom Meet Recruitment Limited Full timeJob Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...
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Regulatory Affairs Specialist
2 weeks ago
United Kingdom Corin Group Full timeCorinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards,...