At a Glance
- Tasks: Lead regulatory strategies for new pharmaceutical products and manage a dynamic team.
- Company: Join the largest healthcare company focused on 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: Relevant degree or experience in pharmaceutical CMC regulatory affairs is essential.
- Other info: This is a 6-month contract role based in High Wycombe with flexible working days.
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-£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 client's 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. 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.
CMC Regulatory Affairs Consultant employer: TieTalent
Contact Detail:
TieTalent 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 and challenges in CMC regulatory affairs.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the EMEA region. This knowledge will not only help you in interviews but also demonstrate your commitment and expertise in the field.
✨Tip Number 3
Prepare to discuss your project management skills in detail. Be ready to share examples of how you've successfully managed regulatory projects, highlighting your ability to lead teams and deliver results under tight deadlines.
✨Tip Number 4
Research the company’s recent product launches and regulatory achievements. Being knowledgeable about their portfolio will allow you to tailor your conversation during interviews and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace CMC Regulatory Affairs Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in CMC regulatory affairs. Focus on your expertise with regulatory classifications, project management skills, and any specific achievements that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to this role. Mention how your background and skills make you a perfect fit for the CMC Regulatory Affairs Consultant position at TieTalent.
Highlight Relevant Qualifications: In your application, emphasise your relevant Bachelor’s degree or equivalent work experience. Be specific about your knowledge of regulatory frameworks in the EU/EMEA and how you can apply this to the role.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is accurate and presented professionally.
How to prepare for a job interview at TieTalent
✨Know Your Regulatory Frameworks
Familiarise yourself with the regulatory frameworks in the EU/EMEA, especially those relevant to CMC. Be prepared to discuss how you have applied this knowledge in previous roles, as it will demonstrate your expertise and readiness for the position.
✨Showcase Project Management Skills
Highlight your project management experience during the interview. Discuss specific projects you've led or contributed to, focusing on how you managed timelines, resources, and stakeholder communication to achieve successful outcomes.
✨Prepare for Team Dynamics
Since the role involves leading a Regulatory Affairs team, be ready to talk about your leadership style and how you foster collaboration. Share examples of how you've built strong partnerships across different departments, such as R&D and Marketing.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects and future goals in regulatory affairs. This shows your genuine interest in the role and helps you assess if the company aligns with your career aspirations.