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For Companies At a Glance
- Tasks: Lead regulatory strategies for new pharmaceutical products and manage a dynamic team.
- Company: Join the largest healthcare company dedicated to improving global health access and affordability.
- Benefits: Enjoy a competitive salary, hybrid work options, and the chance to make a real impact.
- Why this job: Be part of a mission-driven team that values innovation and collaboration in healthcare.
- Qualifications: Bachelor's degree or equivalent experience in pharmaceutical CMC regulatory affairs required.
- Other info: This role is based in High Wycombe with 2-3 days on-site work.
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 contract basis for 6 months.
Salary: £45.00 - £62.93 per hour PAYE or £65.00 - £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 client's site in High Wycombe. This is a hybrid role with 2-3 days expected on site.
Apply: It is essential that applicants hold entitlement to work in the UK. Please quote job reference. Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
If this position isn't suitable but you are looking for a new role, or if you are interested in seeing what opportunities are out there, head over to our LinkedIn page (cka-group) and follow us to see our latest jobs and company news.
CMC Regulatory Affairs Consultant employer: CK Group
Contact Detail:
CK Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC Regulatory Affairs Consultant
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those working in regulatory affairs. Attend industry events or webinars to connect with potential colleagues and learn about the latest trends in CMC regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks in the EMEA region. Understanding the nuances of these regulations can set you apart from other candidates and demonstrate your commitment to the role.
✨Tip Number 3
Showcase your project management skills by discussing relevant experiences where you successfully led a team or managed a project. Highlighting your ability to coordinate with various departments will be crucial for this role.
✨Tip Number 4
Research the company’s recent product launches and regulatory achievements. Being knowledgeable about their portfolio will help you engage in meaningful conversations during interviews and show your genuine interest in their work.
We think you need these skills to ace CMC Regulatory Affairs Consultant
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a CMC Regulatory Affairs Consultant. Familiarise yourself with the specific requirements mentioned in the job description, such as expertise in regulatory classifications and project management skills.
Tailor Your CV: Customise your CV to highlight relevant experience in pharmaceutical CMC regulatory affairs. Emphasise your knowledge of regulatory frameworks in the EU/EMEA and any successful projects you've managed that align with the role's requirements.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of the CMC regulatory landscape. Mention specific examples of how your background aligns with the company's goals and the role's expectations.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
How to prepare for a job interview at CK Group
✨Know Your Regulatory Frameworks
Make sure you have a solid understanding of the regulatory frameworks in the EU/EMEA. Be prepared to discuss how these frameworks apply to CMC strategies and how you've navigated them in your previous roles.
✨Showcase Your Project Management Skills
Highlight your project management experience, especially in relation to regulatory deliverables. Be ready to provide examples of how you've successfully led projects and managed timelines in a regulatory context.
✨Demonstrate Cross-Functional Collaboration
This role requires strong partnerships with various teams. Prepare to discuss how you've collaborated with R&D, Marketing, and Supply Chain in the past, and how you can bring that experience to the table.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in regulatory affairs. Think about challenges you've faced and how you approached them, particularly in relation to new product registrations or line extensions.
