Regulatory Affairs Consultant, CMC

Desired Skills: cmc,regulatory affairs

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
• Strong project management skills.
• 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 anett@peglobal.co.uk

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