Regulatory CMC Writer

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Global Contract Medical Writing and Regulatory Affairs Specialist

Liam Newton has partnered with a small, Clinical stage Biotech who specialise within the Oncology space.

We are seeking a highly motivated and detail-oriented Regulatory CMC Writer to join our team. The successful candidate will be responsible for authoring and managing CMC documentation to support regulatory submissions. This role requires a strong understanding of regulatory requirements and the ability to work collaboratively with cross-functional teams.

Key Responsibilities:

1. Author and review CMC sections of regulatory submissions, including INDs, NDAs, BLAs, and MAAs.
2. Ensure CMC documentation complies with regulatory guidelines and company standards.
3. Collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs teams to gather and interpret data.
4. Maintain up-to-date knowledge of global regulatory requirements and industry best practices.
5. Participate in regulatory strategy meetings and provide CMC-related input.
6. Manage timelines and ensure timely completion of CMC documentation.
7. Assist in responding to regulatory agency questions and requests for additional information.

Qualifications:

1. Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) required; advanced degree preferred.
2. Minimum of 5 years of experience in regulatory writing, with a focus on CMC documentation.
3. Strong understanding of regulatory requirements for CMC in the US and EU.
4. Excellent written and verbal communication skills.
5. Detail-oriented with strong organizational and project management skills.
6. Ability to work independently and as part of a team in a fast-paced environment.
7. Proficiency in Microsoft Office Suite and regulatory submission software.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Writing/Editing and Science

Industries

Biotechnology Research and Pharmaceutical Manufacturing