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Regulatory Affairs Consultant, CMC (Drugs, Dietary Supplements, Medical Devices)

TN United Kingdom

High Wycombe

On-site

GBP 50,000 - 80,000

Full time

Today
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Job summary

Join a leading organization in the Self Care franchise as a Regulatory Affairs CMC Consultant. This role offers a unique opportunity to shape regulatory strategies across the EMEA region, ensuring the success of new product registrations and line extensions. You will play a pivotal role in guiding product development teams while managing compliance with local regulations. With a focus on impactful contributions, this 6-month contract position comes with an attractive rate and the potential for extension, making it an exciting opportunity for seasoned professionals in regulatory affairs.

Benefits

Opportunity for contract extension
Attractive rate
Significant impact on product development

Qualifications

  • Minimum 6 years of regulatory CMC experience for EMEA.
  • Expertise in regulatory classifications for drugs and dietary supplements.

Responsibilities

  • Provide regulatory input and technical guidance to product development teams.
  • Prepare and submit regulatory CMC submissions and maintain compliance.

Skills

Regulatory classifications expertise
Regulatory CMC experience
Project management skills

Job description

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Regulatory Affairs Consultant, CMC (Drugs, Dietary Supplements, Medical Devices), High Wycombe

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Client:
Location:

High Wycombe, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

52fb6eef0f0f

Job Views:

5

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

Your company: Join a leading organization in the Self Care franchise, dedicated to developing and implementing regulatory strategies across the EMEA region. They are committed to ensuring the success of new product registrations, line extensions, and new indications and claims for drugs, dietary supplements, and medical devices.

Your new role: As a Regulatory Affairs CMC Consultant, you will provide regulatory input and technical guidance to product development teams. You will be responsible for supporting the development of the CMC Regulatory strategy in EMEA. Your duties include preparing and submitting regulatory CMC submissions, maintaining compliance with local regulatory and quality system requirements, and managing a team to achieve regulatory objectives. The focus will be on securing new product registrations, extending existing product lines, and obtaining approvals for new indications and claims.

What you'll need to succeed:

  • Expertise in regulatory classifications, including drugs or dietary supplements.
  • Minimum of 6 years of regulatory CMC experience for EMEA.
  • Strong project management skills.

What you'll get in return:

  • An opportunity to make a significant impact on the Self Care franchise.
  • 6-month contract with scope to extend.
  • Attractive rate on offer.
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