Regulatory Affairs Consultant, CMC

PE Global; High Wycombe; On-site; GBP 100,000 - 125,000; Full time

Job summary

Join a leading multi-national consumer health company as a Regulatory Affairs Consultant in High Wycombe. This contract role offers a competitive hourly rate, where you'll be responsible for developing regulatory strategies and leading a team to ensure successful product registrations. Your expertise in regulatory affairs will be key in navigating complex frameworks and collaborating with cross-functional teams. This is an exciting opportunity to make a significant impact in the self-care franchise within a dynamic and supportive environment.

Qualifications

• Expertise in CMC regulatory strategies across EMEA.
• Strong communication skills for articulating complex concepts.

Responsibilities

• Develop regulatory strategies and provide guidance to product teams.
• Lead a Regulatory Affairs team to ensure successful product registrations.

Skills

Regulatory Affairs Expertise

Communication Skills

Technical Guidance

Team Leadership

Regulatory Framework Knowledge

Education

Bachelor's Degree in a Relevant Field

Job description

PE Global High Wycombe, England, United Kingdom

Regulatory Affairs Consultant, CMC

PE Global High Wycombe, England, United Kingdom

4 days ago Be among the first 25 applicants

Direct message the job poster from PE Global

Recruitment Consultant (CertRP) / PE Global / Connecting people with the right opportunities

PE Global is currently recruiting for a Regulatory Affairs Consultant, CMC for a leading multi-national consumer health company in High Wycombe.

This is a 6 months contract role paying£75-85 per hour Umbrella. Inside IR35.

Duties of the role/Responsibilities

• Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
• Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims with supportive technical justification/documentation in alignment with the business plan.
• Create an environment of operational excellence through regulatory expertise by managing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives.
• Manages the global &/or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant, within their brand area & geographic responsibility.
• Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain and local business representatives.
• Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams

Education/Experience

• Relevant Bachelor's Degree or higher
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices, mainly pharmaceutical CMC regulatory affairs
• Knowledge of regulatory frameworks and external environments in the EU and wider EMEA , and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory CMC in the markets of relevance
• Proficiency in English
• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV to [e-mail]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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