CMC Regulatory Affairs Consultant

TieTalent; High Wycombe; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a CMC Regulatory Affairs Consultant to join their team in High Wycombe. This hybrid role offers the opportunity to develop regulatory strategies across the EMEA, manage a dedicated team, and ensure the successful registration of new products. Ideal candidates will possess a relevant Bachelor's degree and have a solid understanding of regulatory frameworks. Join a forward-thinking company that values innovation and collaboration in the pharmaceutical sector, where your expertise will contribute to improving healthcare access and affordability.

Qualifications

• Relevant Bachelor's Degree or equivalent work experience in pharmaceutical CMC regulatory affairs.
• Expertise across a broad spectrum of Regulatory classifications including Drugs and Medical Devices.

Responsibilities

• Responsible for the development of CMC/technical regulatory strategies across the EMEA.
• Leads a Regulatory Affairs team ensuring the success of new product registrations.

Skills

Regulatory Affairs

Project Management

Pharmaceutical Knowledge

Communication Skills

Education

Bachelor's Degree in Pharmaceutical Sciences

Job description

TieTalent High Wycombe, England, United Kingdom

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About

CK Group are recruiting for a CMC Regulatory Affairs Consultant to join a company in the Pharmaceutical industry at their site based in High Wycombe on a on a contract basis for 6 months.

Salary

£45-£62.93 per hour PAYE or £65-84.55 per hour Umbrella

About

CK Group are recruiting for a CMC Regulatory Affairs Consultant to join a company in the Pharmaceutical industry at their site based in High Wycombe on a on a contract basis for 6 months.

Salary

£45-£62.93 per hour PAYE or £65-84.55 per hour Umbrella

CMC Regulatory Affairs Consultant Role

• Responsible for the development of CMC/technical regulatory strategies across the EMEA
• Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims
• Manages the global or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant
• Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain & local business representatives.
• Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional & business Leadership teams
  
  

Your Background

• Relevant Bachelor's Degree or equivalent work experience in pharmaceutical CMC regulatory affairs
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices
• Knowledge of regulatory frameworks and external environments in the EU/ EMEA , & 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.
  
  

Company

Our client is the largest and most broadly-based healthcare company. They strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere.

Location:

This role is based at our clients site in High Wycombe. This is a hybrid role with 2-3 days expected on site.

Apply

For more information, or to apply for this CMC Regulatory Affairs Consultant role please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference (Apply online only).

It is essential that applicants hold entitlement to work in the UK

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check

Nice-to-have skills

• Project Management
• High Wycombe, England
  
  

Work experience

• Administrative
• General Project Management
• Legal
  
  

Languages

• English

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Technology, Information and Internet

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