Senior CMC Regulatory Technical Writer

Senior CMC Regulatory Technical Writer

Immediate contract hire required until end March 2025 with a high likelihood of a 6 month extension.

The position can be based in Paris (hybrid) or remotely within the UK/EU.

Partnering with a highly reputable, international and well-recognised pharmaceutical company, we are looking to appoint an experienced CMC Regulatory Technical Writer to join their team.

This role demands exceptional writing skills to clearly, concisely, and accurately present the drug development activities and scientific foundations that ensure the quality of our medicines in CMC regulatory dossiers, meeting global health authority standards. Collaboration with cross-functional teams, including CMC regulatory strategists, drug substance and product development, commercial manufacturing, and quality assurance, is essential. The chosen candidate will also develop and maintain a suite of CMC regulatory dossier templates.

As a technical writer, you will work closely with the CMC regulatory strategist to fulfill your responsibilities, without being solely responsible for developing the regulatory strategy for assigned projects.

Education and Required Skills

1. Degree in Pharmacy or a relevant science/technical subject such as chemistry, biology, or related field.
2. Minimum of 10 years within a CMC role in the pharmaceutical industry, with at least 5 years being directly involved with a CMC regulatory submission technical writing role.
3. Significant knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
4. Proficient in MS Office applications and information regulatory information management software (e.g., eCTD, Veeva).
5. Proficient in written and spoken English.