Senior Regulatory CMC Manager

Hobson Prior; High Wycombe; On-site; GBP 45,000 - 70,000; Full time

Job summary

Hobson Prior seeks a Sr. Regulatory Chemistry, Manufacturing, and Controls Manager to lead a team in managing the lifecycle of pharmaceutical products. This role emphasizes regulatory compliance and strategic planning across EMEA. If you're an innovative thinker ready to make a difference, apply now.

Qualifications

• Expertise in regulatory classifications such as drugs, dietary supplements, or medical devices.
• Understanding of regulatory frameworks applicable throughout the product lifecycle.
• Experience managing submissions for various dosage forms.

Responsibilities

• Develop strategies ensuring regulatory compliance for product approvals.
• Manage risks and oversee the creation of regulatory documentation.
• Lead interactions with health authorities.

Skills

Leadership

Regulatory knowledge

Communication

Education

Bachelor's degree or higher in a relevant field

Job description

6 days ago Be among the first 25 applicants

Direct message the job poster from Hobson Prior

Consultant - Regulatory Affairs at Hobson Prior

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.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.hobsonprior.com/privacy-policy

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Professional Services

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