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For Companies At a Glance
- Tasks: Support regulatory submissions and lifecycle management for biologics and pharmaceuticals.
- Company: Join a dynamic team focused on innovative therapies and compliance in the biotech industry.
- Benefits: Enjoy flexible freelance work with opportunities to shape impactful projects.
- Why this job: Be at the forefront of drug development, influencing global health outcomes.
- Qualifications: Bachelor's or higher in a scientific field with significant CMC regulatory experience required.
- Other info: Ideal for those passionate about compliance and innovation in healthcare.
The predicted salary is between 48000 - 72000 £ per year.
We are seeking an experienced freelance CMC Regulatory Affairs Consultant to support the development, submission, and lifecycle management of regulatory CMC documentation for biologics, pharmaceuticals and/or advanced therapies. The consultant will provide strategic and operational guidance to ensure compliance with global regulatory requirements, while supporting product development and commercialization objectives.
Key Responsibilities
- Develop, review, and submit high-quality CMC sections (Modules 2 & 3) of regulatory submissions (e.g., INDs, IMPDs, NDAs, BLAs, MAAs, amendments, supplements, variations).
- Provide strategic CMC regulatory advice during development and lifecycle phases, including late-stage development and post-marketing.
- Serve as a liaison between Regulatory Affairs, Manufacturing, Quality, and R&D to ensure alignment of regulatory strategy with product development.
- Interpret and apply global regulatory guidance (e.g., FDA, EMA, ICH) to CMC activities.
- Support interactions with regulatory agencies, including preparation for meetings (e.g., pre-IND, end-of-Phase 2, pre-BLA/MAA).
- Monitor evolving regulatory CMC requirements and assess their impact on current and future submissions.
- Review and assess changes to manufacturing processes and controls for regulatory impact and develop appropriate submission strategies.
- Ensure timely and compliant execution of regulatory submissions and responses to health authority queries.
Qualifications
- Bachelor's, Master's, or PhD in Chemistry, Pharmacy, Biology, or a related scientific discipline.
- Significant experience in CMC regulatory affairs within the pharmaceutical or biotechnology industry.
- In-depth knowledge of global regulatory requirements for drug substance and drug product development and manufacturing.
- Demonstrated experience with successful regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs).
- Strong understanding of quality systems, GMP, and ICH guidelines.
- Excellent written and verbal communication skills.
- Ability to work independently and manage multiple projects simultaneously in a fast-paced environment.
Preferred Qualifications
- Prior consulting experience or experience working with regulatory authorities.
- Experience with cell and gene therapies, biologics, or combination products.
Contact Detail:
Pop Science 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 CMC regulatory affairs field. Attend industry conferences, webinars, and workshops to meet potential colleagues and learn about the latest trends and requirements in regulatory submissions.
✨Tip Number 2
Stay updated on global regulatory guidelines from agencies like the FDA and EMA. Familiarise yourself with recent changes in regulations that could impact CMC documentation, as this knowledge will be crucial during interviews.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with successful regulatory submissions. Highlight your strategic approach and how you navigated challenges in previous roles to demonstrate your expertise.
✨Tip Number 4
Research StudySmarter's current projects and values. Understanding our mission and how your skills align with our goals can help you articulate why you're a great fit for the role during any discussions.
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, particularly with biologics and pharmaceuticals. Emphasise your successful regulatory submissions and any consulting experience.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the key responsibilities outlined in the job description. Showcase your strategic thinking and operational guidance skills, and explain how your background aligns with their needs.
Highlight Relevant Qualifications: In your application, clearly state your educational background and any specific qualifications related to Chemistry, Pharmacy, or Biology. Mention your understanding of global regulatory requirements and quality systems.
Showcase Communication Skills: Since excellent written and verbal communication skills are crucial for this role, ensure your application is well-structured and free of errors. Consider including examples of how you've effectively communicated with regulatory authorities in the past.
How to prepare for a job interview at Pop Science
✨Know Your CMC Regulations
Make sure you have a solid understanding of global regulatory requirements, especially those related to CMC documentation for biologics and pharmaceuticals. Brush up on the latest guidelines from agencies like the FDA and EMA, as this knowledge will be crucial during your interview.
✨Showcase Your Experience
Prepare to discuss your previous experience with regulatory submissions, particularly INDs, NDAs, and BLAs. Be ready to provide specific examples of successful submissions you've been involved in, highlighting your role and the impact of your contributions.
✨Demonstrate Strategic Thinking
During the interview, emphasise your ability to provide strategic CMC regulatory advice. Discuss how you've navigated complex regulatory landscapes in past roles and how you can apply that experience to support product development and compliance at their company.
✨Prepare for Scenario Questions
Expect scenario-based questions where you may need to interpret regulatory guidance or assess the impact of changes in manufacturing processes. Practise articulating your thought process and decision-making skills in these situations to demonstrate your expertise.
