The Fountain Group ยท 1 month ago
CMC Regulatory Technical Writer II - Remote
United States
Full-time
Remote
Senior Level
$57/hr - $57/hr
5+ years expThe Fountain Group is currently seeking a CMC Regulatory Technical Writer II for a prominent client of theirs. The role involves developing and authoring CMC common technical documents for regulatory dossiers and ensuring compliance with regulatory guidelines while collaborating with various stakeholders.
ConsultingRecruitingStaffing Agency
Responsibilities
The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers within pre-established timelines
This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports
Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs
The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:
Following regulatory guidelines, source documentation, and Sanofi's templates
Collaborating and coordinating with key stakeholders across the GBU's, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
Avoiding unsolicited regulatory burden
Supporting the development of regulatory risk mitigation strategies
Maintaining up-to-date knowledge of Sanofi's ways of working, SOPs, and CMC regulations and guidelines
Supporting the planning and preparation of timelines
Qualification
Required
Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3)
The candidate must have at least 5 years' experience in the pharmaceutical industry
Experience with MS suite of software applications is expected
Excellent interpersonal communication skills are required
The candidate must have previously demonstrated the ability to interact within a multi-disciplinary team
The candidate needs very little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated
Knowledge of US pharmaceutical Regulations is essential
Education: BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field)
Preferred
A background in pharmaceutical manufacturing or quality control/quality assurance is a plus
Expertise with document management systems such as Veeva or Documentum is a plus
A working knowledge of cGMP's is desired
Medical device experience is a plus
Exposure to ex-US Regulations is desired, but not mandatory
Company
The Fountain Group
The Fountain Group is a staffing firm that specializes in rendering contingent workforce solutions to various industries.
501-1000 employees
H1B Sponsorship
The Fountain Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
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2025 (52)
2024 (34)
2023 (21)
2022 (42)
2021 (41)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Jahnavi Patel
Finance Business Partner
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