Senior Regulatory CMC Manager

Hobson Prior International Ltd; High Wycombe; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading life sciences recruiter is seeking a Sr. Regulatory Chemistry, Manufacturing, and Controls Manager to lead a team in ensuring regulatory compliance and strategic planning for product approvals in the EMEA region. The successful candidate will possess strong leadership skills and a deep understanding of regulatory frameworks, contributing to the lifecycle management of pharmaceutical products.

Qualifications

• Expertise in regulatory classifications such as drugs, dietary supplements, or medical devices.
• Understanding of regulatory frameworks and application throughout the product lifecycle.
• Knowledge of post-approval changes and global market requirements.

Responsibilities

• Develop and implement strategies for regulatory compliance in product approvals.
• Oversee creation of regulatory documents ensuring they meet global standards.
• Manage risks associated with product lifecycle maintenance and communicate effectively.

Skills

Leadership

Regulatory Compliance

Strategic Planning

Communication

Project Management

Education

Bachelor's degree or higher in a relevant field

Job description

We are on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.

Hobson Prior is seeking a Sr. Regulatory Chemistry, Manufacturing, and Controls Manager to lead a team focused on managing the lifecycle of pharmaceutical products in the EMEA region. This role emphasizes regulatory compliance and strategic planning for product approvals.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop and implement strategies to ensure regulatory compliance for product approvals.
• Identify necessary documents and address any issues related to content, quality, or timelines for submissions.
• Oversee the creation and review of regulatory documents, ensuring they meet global standards and timelines.
• Manage risks associated with product lifecycle maintenance and communicate strategies and issues to teams.
• Lead interactions with health authorities, including preparing for meetings and negotiations.
• Foster a culture of excellence by guiding and developing team members and collaborating with other departments.
• Build strong partnerships with research, operations, and local regulatory teams.

Key Skills and Requirements:

• Bachelor's degree or higher in a relevant field.
• Expertise in regulatory classifications such as drugs, dietary supplements, or medical devices.
• Understanding of regulatory frameworks and ability to apply them throughout the product lifecycle.
• Knowledge of post-approval changes and requirements for global markets.
• Experience in managing submissions for various dosage forms.
• Strong leadership and coaching abilities.
• Proficiency in English.

For more information, please contact Henry LeLacheur.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

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

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