Regulatory CMC Consultant
Posted 1 day ago by Walker Cole International
Negotiable
Undetermined
Undetermined
England, United Kingdom
Summary: The Regulatory CMC Consultant will provide strategic and operational support for small molecule pharmaceutical products, focusing on Chemistry, Manufacturing, and Controls (CMC) activities. The role involves ensuring compliance with global regulatory requirements and managing change controls throughout the product lifecycle. The candidate must be available for interviews before Christmas and be ready to start as soon as possible.
Key Responsibilities:
- Develop and execute CMC regulatory strategies for small molecule development and commercial products.
- Author, review, and submit CMC sections of regulatory filings (IND, NDA, MAA, variations, supplements) for small molecules.
- Lead and manage change control processes in compliance with GMP and regulatory expectations.
- Collaborate with cross-functional teams (Quality, Manufacturing, Regulatory Affairs) to ensure timely and accurate documentation.
- Monitor regulatory updates relevant to small molecules and advise on impact to CMC processes and submissions.
- Support responses to health authority queries related to CMC for small molecule products.
Key Skills:
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or related discipline.
- Strong experience in Regulatory Affairs with a focus on CMC for small molecules.
- Proven experience in change control management within a GMP environment.
- In-depth knowledge of ICH guidelines, FDA, EMA, and other global regulatory requirements for small molecules.
- Strong technical writing and communication skills.
- Ability to work independently in a remote setting and manage multiple priorities.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
We are currently recruiting an experienced Regulatory CMC Consultant to provide strategic and operational support for small molecule pharmaceutical products. This role will focus on Chemistry, Manufacturing, and Controls (CMC) activities, ensuring compliance with global regulatory requirements and managing change controls throughout the product lifecycle. This requires someone available to interview before Christmas with a start ASAP.
Key Responsibilities:
- Develop and execute CMC regulatory strategies for small molecule development and commercial products.
- Author, review, and submit CMC sections of regulatory filings (IND, NDA, MAA, variations, supplements) for small molecules.
- Lead and manage change control processes in compliance with GMP and regulatory expectations.
- Collaborate with cross-functional teams (Quality, Manufacturing, Regulatory Affairs) to ensure timely and accurate documentation.
- Monitor regulatory updates relevant to small molecules and advise on impact to CMC processes and submissions.
- Support responses to health authority queries related to CMC for small molecule products.
Requirements:
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or related discipline.
- Strong experience in Regulatory Affairs with a focus on CMC for small molecules.
- Proven experience in change control management within a GMP environment.
- In-depth knowledge of ICH guidelines, FDA, EMA, and other global regulatory requirements for small molecules.
- Strong technical writing and communication skills.
- Ability to work independently in a remote setting and manage multiple priorities.