Global Regulatory Affairs Director
6 days ago
Northreach has partnered with a leading pharma company in the UK to recruit a Global Head of Regulatory Affairs to lead their regulatory team.
Key Responsibilities:- Lead the regulatory team, interfacing with regulatory agencies like the MHRA, EMA, and FDA, and preparing and submitting regulatory documents.
- Develop and implement regulatory strategies, managing local regulatory partners, and ensuring robust data management systems are in place.
- Oversee the preparation, submission, and ongoing management of regulatory documents, ensuring adherence to local and international regulations.
- Provide cross-functional leadership, coordinating with internal and external teams to ensure alignment with regulatory requirements.
- Lead and develop the regulatory team, enhancing their knowledge, skills, and capabilities to support the company's strategic objectives.
- Serve as the primary liaison with regulatory agencies, managing communications and facilitating timely approvals.
- Monitor global regulatory developments to ensure continuous compliance of products throughout their lifecycle.
- Identify potential regulatory risks and develop effective mitigation strategies.
- Lead training and mentorship initiatives within the regulatory affairs team, fostering regulatory expertise and growth within the organization.
Requirements:
- Extensive background in regulatory affairs within the pharmaceutical, biotech, or medical device industries, with experience in global markets such as the US, EU, and Rest of World (ROW).
- Comprehensive knowledge of regulatory requirements and guidelines from agencies like the FDA, EMA, and others.
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6 days ago
London, Greater London, United Kingdom Northreach Full timeGlobal Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a seasoned professional to lead their regulatory affairs team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Lead the creation and execution of comprehensive regulatory plans...
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Global Regulatory Affairs Director
6 days ago
London, Greater London, United Kingdom Northreach Full timeGlobal Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a seasoned professional to lead their regulatory affairs team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Lead the creation and execution of comprehensive regulatory plans...
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Global Regulatory Affairs Director
6 days ago
London, Greater London, United Kingdom Northreach Full timeGlobal Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a seasoned professional to lead their regulatory affairs team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Lead the creation and execution of comprehensive regulatory plans...
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Global Regulatory Affairs Director
6 days ago
London, Greater London, United Kingdom Northreach Full timeGlobal Head of Regulatory AffairsNorthreach is partnering with a leading pharma company in the UK to find a seasoned professional to lead their regulatory affairs team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with local and international regulations.Lead the creation and execution of comprehensive regulatory plans...