Associate Director Regulatory Compliance
4 weeks ago
Our Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. The Regulatory CMC Development Associate Director will play a pivotal role in the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for our product development programs. This individual will be responsible for leading CMC regulatory submissions and ensuring compliance with global regulatory requirements. The ideal candidate will possess a strong background in pharmaceutical manufacturing, regulatory affairs, and CMC documentation.
Regulatory Strategy Development:
Develop and implement CMC regulatory strategies for drug development programs.
Provide regulatory guidance and expertise to cross-functional teams throughout the product lifecycle.
Lead the preparation, review, and submission of high-quality CMC sections of regulatory documents (e.g., Ensure that CMC documentation meets global regulatory requirements and guidelines.
Regulatory Compliance and Communication:
Monitor and interpret global CMC regulatory requirements and ensure company compliance.
Liaise with regulatory agencies to facilitate CMC submissions and address regulatory inquiries.
Work closely with R&D, Quality, Manufacturing, and other departments to gather necessary data and documentation.
Support the development and implementation of CMC regulatory strategies for new products and lifecycle management of existing products.
Mentor and train junior regulatory staff on CMC regulatory processes and requirements.
Foster a collaborative and innovative regulatory environment within the team.
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Associate Director Regulatory Compliance
2 weeks ago
United Kingdom Regeneron Full timeWe are seeking an outstanding individual to lead our GPS Quality & Compliance team. We hope you are excited about the opportunity to contribute the growth of our Quality and Compliance team. As an Associate Director, GPS Quality and Compliance a typical day might include the following: Developing and implementing compliance and quality oversight...
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Associate Director Regulatory Compliance
2 weeks ago
United Kingdom Regeneron Full timeWe are seeking an outstanding individual to lead our GPS Quality & Compliance team. We hope you are excited about the opportunity to contribute the growth of our Quality and Compliance team. As an Associate Director, GPS Quality and Compliance a typical day might include the following: Developing and implementing compliance and quality oversight...
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Associate Director Regulatory Compliance
2 weeks ago
United Kingdom Regeneron Pharmaceuticals, Inc Full timeWe are seeking an outstanding individual to lead our GPS Quality & Compliance team. We hope you are excited about the opportunity to contribute the growth of our Quality and Compliance team. As an Associate Director, GPS Quality and Compliance a typical day might include the following: Developing and implementing compliance and quality oversight governance...
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Compliance - Associate Director
4 weeks ago
United Kingdom Bruin Financial Full timeAssociate Director, Compliance Officer About my Investment Management client: My Investment Management client is a leading provider of alternative credit strategies with extensive European operations and a commitment to transparency and sustainability. Seeking an experienced Compliance Officer for our Luxembourg team. Design and implement compliance...
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Compliance - Associate Director
4 weeks ago
United Kingdom Bruin Financial Full timeAssociate Director, Compliance Officer About my Investment Management client: My Investment Management client is a leading provider of alternative credit strategies with extensive European operations and a commitment to transparency and sustainability. Seeking an experienced Compliance Officer for our Luxembourg team. Design and implement compliance...
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Director/Associate Director | Compliance
1 month ago
United Kingdom Autolus Ltd Full timeVacancy for Associate Director/ Director - Medical Writing Regulatory Affairs Location: UK - White City, West London & Hybrid With an expanding regulatory team, an exciting opportunity has arisen for an Associate Director or a Director to join the Autolus Regulatory and Medical Writing team to support global expansion of our cell and gene therapy...
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Director/Associate Director | Compliance
2 months ago
United Kingdom Autolus Ltd Full timeVacancy for Associate Director/ Director - Medical Writing Regulatory Affairs Location: UK - White City, West London & Hybrid With an expanding regulatory team, an exciting opportunity has arisen for an Associate Director or a Director to join the Autolus Regulatory and Medical Writing team to support global expansion of our cell and gene therapy...
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Director, Regulatory
4 weeks ago
United Kingdom Walker Cole International Full timeDirector of Regulatory Affairs Walker Cole International are delighted to be partnering with a large IVD multinational, who are looking to hire a Director of Regulatory Affairs. This is a fully remote position that requires up to 20% travel. The successful candidate will lead a dynamic team, oversee all regulatory activities, and be responsible for the...
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Director, Regulatory
4 weeks ago
United Kingdom Walker Cole International Full timeDirector of Regulatory Affairs Walker Cole International are delighted to be partnering with a large IVD multinational, who are looking to hire a Director of Regulatory Affairs. This is a fully remote position that requires up to 20% travel. The successful candidate will lead a dynamic team, oversee all regulatory activities, and be responsible for the...
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Director, Regulatory
4 weeks ago
United Kingdom Real Staffing Group Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
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Director, Regulatory
4 weeks ago
United Kingdom Real Staffing Group Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
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Director, Regulatory
4 weeks ago
United Kingdom Real Staffing Group Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
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Compliance Associate
2 months ago
United Kingdom Compliance Professionals Full timeTHE COMPANY: Our client is a leading global investment manager, with £billions in AUM. THE RESPONSIBILITIES: Financial Crime – The candidate will be responsible for ensuring that the AML/CTF process of the firm are effective and robust. They will assume day to day responsibility for the AML process including client onboarding, ongoing due diligence,...
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Director of Compliance
2 months ago
United Kingdom EC1 Partners Ltd Full timeCompliance Director I am partnered with a fintech company focusing on capital markets that helps financial institutions transition liquidity. They are currently looking for an experienced, hands-on Director of Compliance to join their London office! Responsibilities: Manage the regulatory risk profile of the business and operations, including providing...
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Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary:The...
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Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
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Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
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Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary:The...
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Associate Director Global Regulatory CMC
4 weeks ago
United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary: ...
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Regulatory Compliance Manager
1 month ago
United Kingdom Compliance Professionals Full timeOur client is a multinational banking organisation. Good experience of tracking and operationally implementing AML regulations Good and practical understanding of financial crime matters Good and practical understanding of CDD/KYC customer on-boarding Good breadth of tracking and implementing the relevant regulatory Good and practical...