Regulatory Executive Senior

Proclinical Staffing; Remote; GBP 125,000 - 150,000; Full time

Job summary

A leading life sciences recruiter is seeking a Regulatory Executive Senior to oversee global Chemistry, Manufacturing, and Controls (CMC) regulatory marketing applications. The role involves developing and executing CMC strategies, ensuring compliance with regulatory standards, and managing multiple projects remotely. The ideal candidate will have expertise in global regulatory guidelines and proven project management skills. This position offers the opportunity to shape impactful regulatory strategies affecting global pharmaceutical markets.

Qualifications

• Strong understanding of global CMC regulatory guidelines, procedures, and policies.
• Proven ability to manage multiple projects and adapt to shifting priorities.
• Expertise in developing and executing CMC strategies for regulatory submissions.
• Skilled in risk assessment and mitigation related to regulatory submissions.
• Effective communication and leadership skills to influence and guide teams.
• Analytical mindset with the ability to evaluate data and regulatory precedents.
• Experience in supporting inspections and addressing quality-related challenges.

Responsibilities

• Develop and drive CMC strategies for global and regional submissions.
• Ensure timely and compliant CMC regulatory submissions.
• Take accountability for submission content and alignment with regional requirements.
• Provide expert advice on regulations, guidelines, and policies.
• Identify potential risks and propose risk mitigation strategies.
• Deliver CMC regulatory strategies for major inspections or quality incidents.
• Manage activities across multiple complex projects and teams.
• Evaluate data and the regulatory environment for strategic direction.
• Assess and improve CMC regulatory processes and systems.

Skills

Global CMC regulatory guidelines

Project management

CMC strategies execution

Risk assessment

Communication and leadership

Analytical skills

Inspection support

Job description

Work from anywhere and shape powerful regulatory strategies that drive results! Enjoy the freedom of remote work while making a global impact.

Proclinical is seeking a Regulatory Executive Senior to manage and accelerate global Chemistry, Manufacturing, and Controls (CMC) regulatory marketing applications and early lifecycle activities. In this role, you will provide strategic guidance on global regulatory requirements, ensuring compliance with evolving standards while supporting the development, registration, and manufacturing of pharmaceutical products. This is a remote working position which requires adaptability to changing priorities and the ability to manage multiple projects simultaneously.

Responsibilities :

• Develop and drive CMC strategies for global and regional submissions to support product development, registration, and lifecycle maintenance.
• Ensure timely and compliant CMC regulatory submissions to enable rapid product launches and maintain market supply continuity.
• Take accountability for submission content, ensuring alignment with regional requirements to minimize regulatory questions and maximize flexibility in supply, production, and quality.
• Provide expert advice on regulations, guidelines, and policies related to pharmaceutical product development, registration, and manufacturing.
• Identify potential risks associated with submission data and propose clear risk mitigation strategies.
• Deliver CMC regulatory strategies to support major inspections or address quality incidents.
• Manage activities across multiple complex projects and teams simultaneously.
• Evaluate data and the regulatory environment to provide strategic direction, supporting conclusions with evidence and presenting alternative viewpoints when necessary.
• Assess and improve CMC regulatory processes, policies, and systems to enhance departmental efficiency and quality.

Key Skills and Requirements :

• Strong understanding of global CMC regulatory guidelines, procedures, and policies.
• Proven ability to manage multiple projects and adapt to shifting priorities.
• Expertise in developing and executing CMC strategies for regulatory submissions.
• Skilled in risk assessment and mitigation related to regulatory submissions.
• Effective communication and leadership skills to influence and guide teams.
• Analytical mindset with the ability to evaluate data and regulatory precedents.
• Experience in supporting inspections and addressing quality-related challenges.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at [e-mail].

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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