Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support regulatory submissions and lifecycle management for biologics and pharmaceuticals.
- Company: Join a dynamic team focused on compliance and innovation in the biotech industry.
- Benefits: Enjoy flexible freelance work with opportunities for professional growth and networking.
- Why this job: Make a real impact in drug development while collaborating with top industry experts.
- Qualifications: Bachelor's, Master's, or PhD in a scientific field; significant CMC regulatory experience required.
- Other info: Ideal for those passionate about advancing healthcare through regulatory excellence.
The predicted salary is between 36000 - 60000 £ 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.
CMC Regulatory Affairs Consultant employer: Pop Science
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, or local meetups to connect with others who may have insights or job leads. Building relationships can often lead to opportunities that aren't advertised.
✨Tip Number 2
Stay updated on the latest global regulatory changes and trends. Subscribe to relevant newsletters or follow regulatory bodies like the FDA and EMA on social media. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare for potential interviews by familiarising yourself with common CMC regulatory scenarios and challenges. Be ready to discuss how you've navigated complex regulatory submissions in the past, showcasing your problem-solving skills and strategic thinking.
✨Tip Number 4
Consider reaching out to current or former employees of StudySmarter to gain insights into the company culture and expectations for the CMC Regulatory Affairs Consultant role. This can provide you with valuable information to tailor your approach during the application process.
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 any successful regulatory submissions you've been involved in, such as INDs or BLAs.
Craft a Strong Cover Letter: In your cover letter, clearly articulate your understanding of global regulatory requirements and how your background aligns with the key responsibilities of the role. Mention specific examples of your strategic advice during product development.
Highlight Relevant Qualifications: Ensure you mention your educational background in Chemistry, Pharmacy, Biology, or related fields. If you have consulting experience or have worked with regulatory authorities, make that clear as it’s preferred for this position.
Showcase Communication Skills: Since excellent written and verbal communication skills are essential, consider including a brief example of how you've effectively communicated complex regulatory information to stakeholders 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 specifics of INDs, NDAs, and BLAs, as well as any recent changes in regulations that could impact submissions.
✨Showcase Your Experience
Be prepared to discuss your previous experience with successful regulatory submissions. Highlight specific examples where you provided strategic advice or managed complex projects, particularly in late-stage development or post-marketing scenarios.
✨Communicate Effectively
Since excellent communication skills are crucial for this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex regulatory concepts in simple terms, as you may need to liaise with various departments like Manufacturing and R&D.
✨Prepare for Regulatory Agency Interactions
Familiarise yourself with the types of meetings you might have with regulatory agencies, such as pre-IND or end-of-Phase 2 meetings. Think about how you would prepare for these interactions and what strategies you would employ to ensure alignment with regulatory expectations.
