Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Provide strategic regulatory guidance and mentor junior staff in biologics.
- Company: Join a leading global regulatory consultancy focused on life sciences.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and mentorship.
- Why this job: Shape product development strategies and make a real impact in the biotech industry.
- Qualifications: PhD/MSc/BSc in a science discipline with 10+ years in CMC development.
- Other info: Work with top-tier clients and be part of a fast-growing team.
The predicted salary is between 72000 - 108000 £ per year.
A leading global regulatory consultancy is seeking a Principal Consultant (CMC – Biologics) to join its fast-growing team. This senior, full-time role offers the opportunity to provide strategic regulatory and technical guidance to global clients while mentoring junior staff and shaping product development strategies across biologics and advanced therapies.
Key Responsibilities
- Deliver strategic and technical CMC regulatory advice for global drug development programs
- Author and review regulatory documents (INDs, IMPDs, MAAs, BLAs, etc.)
- Lead client engagements and represent them during regulatory interactions
- Oversee project budgets and timelines, ensuring high-quality service delivery
Requirements
- PhD/MSc/BSc in a life or physical science discipline
- 10+ years’ experience in CMC development and regulatory affairs
- Expertise with biologics, including recombinant proteins, antibodies, vaccines, biosimilars, and ATMPs
- Deep knowledge of FDA, EMA, ICH, and TGA regulatory guidelines
- Experience in authoring major submissions and representing clients before regulators
Contact Detail:
Life Sciences Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Consultant (CMC - Biologics)
✨Tip Number 1
Network with professionals in the life sciences and regulatory affairs sectors. Attend industry conferences, webinars, and workshops to connect with potential colleagues and mentors who can provide insights into the role and company culture.
✨Tip Number 2
Stay updated on the latest trends and changes in CMC regulations for biologics. Familiarise yourself with recent FDA, EMA, and ICH guidelines, as this knowledge will be crucial during interviews and discussions with potential employers.
✨Tip Number 3
Prepare to discuss your experience in leading client engagements and managing project timelines. Be ready to share specific examples of how you've successfully navigated regulatory interactions and delivered high-quality service.
✨Tip Number 4
Consider reaching out to current or former employees of the consultancy to gain insights into their experiences. This can help you understand what they value in a Principal Consultant and tailor your approach accordingly.
We think you need these skills to ace Principal Consultant (CMC - Biologics)
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Principal Consultant position. Make sure you understand the key responsibilities and requirements, especially regarding CMC development and regulatory affairs in biologics.
Tailor Your CV: Customise your CV to highlight relevant experience in CMC regulatory advice, authoring regulatory documents, and any leadership roles you've held. Emphasise your expertise with biologics and familiarity with regulatory guidelines.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the life sciences industry and your specific qualifications for the role. Mention your experience with FDA, EMA, ICH, and TGA guidelines, and how you can contribute to the company's success.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail and professionalism, which is crucial in the regulatory consultancy field.
How to prepare for a job interview at Life Sciences Recruitment
✨Showcase Your Expertise
Make sure to highlight your extensive experience in CMC development and regulatory affairs. Be prepared to discuss specific projects you've worked on, especially those involving biologics, as this will demonstrate your capability to provide strategic guidance.
✨Understand Regulatory Guidelines
Familiarise yourself with the latest FDA, EMA, ICH, and TGA regulatory guidelines. Being able to reference these during your interview will show that you are up-to-date and knowledgeable about the regulatory landscape.
✨Prepare for Client Engagement Scenarios
Think of examples where you've successfully led client engagements or represented clients during regulatory interactions. This will help you illustrate your leadership skills and ability to manage client relationships effectively.
✨Demonstrate Mentorship Skills
Since mentoring junior staff is part of the role, be ready to discuss your experience in guiding and developing others. Share specific instances where you've helped team members grow, as this will reflect your commitment to team success.
