CMC Regulatory Technical Writer II - Remote

The Fountain Group is currently seeking a CMC Regulatory Technical Writer II for a prominent client. This role is Remote (though those local to the Morristown area are expected to work hybrid).

Pay: $57/Hour
Duration: 11 months

The CMC Regulatory Technical Writer II is a member of the CMC Dossier Development team and supports Sanofi’s lifecycle management (LCM) programs. The writer collaborates directly with Sanofi’s global business units—Specialty Care, Vaccines, General Medicines, and Consumer Healthcare—by contributing to U.S., EU, and ROW dossiers (e.g., NDA, MAA, IND, and IMPD).

• Develop and author chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines, including responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports.
• Author and evaluate change controls for global regulatory impact and, when required, author technical reports, position papers, white papers, or SOPs.
• Follow regulatory guidelines, source documentation, and Sanofi’s templates.
• Collaborate and coordinate with key stakeholders across the GBU’s, contract manufacturing organizations (CMO), and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA).
• Avoid unsolicited regulatory burden.
• Support the development of regulatory risk mitigation strategies.
• Maintain up‑to‑date knowledge of Sanofi’s ways of working, SOPs, and CMC regulations and guidelines.
• Support the planning and preparation of timelines.

• Experience with CMC and CTD authoring (Modules 2 and 3).
• Background in pharmaceutical manufacturing or quality control/quality assurance (plus).
• At least 5 years’ experience in the pharmaceutical industry.
• Expertise with document management systems such as Veeva or Documentum.
• Working knowledge of cGMPs.
• Proficiency with the MS Office suite.
• Experience with small molecules and aseptically manufactured products; medical device experience (plus).

Must demonstrate excellent interpersonal communication, the ability to work independently within a multi‑disciplinary team, strong prioritization skills, high organization, meticulous attention to detail, and self‑motivation. Knowledge of U.S. pharmaceutical regulations is essential; exposure to ex‑U.S. regulations is desired but not mandatory.

BS/BA, MS, or PhD from an accredited school in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or a related field).