Planet Pharma · 5 hours ago
CMC Technical Writer, MSAT
Conshohocken, PA
Full-time
Hybrid
Senior Level, Lead/Staff
15+ years expPlanet Pharma is seeking a highly experienced CMC Technical Writer to serve as the primary author for global regulatory submissions supporting commercial pharmaceutical products. This role involves full ownership of complex CMC content and offers significant impact on regulatory strategy and submission quality.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Independently author and revise complex CMC sections for global regulatory submissions, including original applications, supplements, variations, and technical responses
Translate MSAT, manufacturing, and CMO data into clear, accurate, regulator-ready content
Ensure documentation accurately reflects process understanding, control strategies, and commercial manufacturing activities
Partner with MSAT SMEs to capture, structure, and articulate detailed product and process knowledge
Maintain consistency across internal technical documentation and global regulatory filings
Serve as a documentation authority, advising on structure, detail, and clarity
Provide hands-on authorship for global submissions (FDA, EMA, international agencies)
Prepare and refine technically complex responses to health authority questions
Support inspection preparation through high-quality, inspection-facing documents
Manage CMC documentation updates to support post-approval changes
Ensure global consistency across historical and current filings
Support documentation for change controls, deviations, investigations, and process changes
Work directly with CMOs to obtain and integrate technical information
Support onboarding of new manufacturing partners with accurate documentation capture
Deliver inspection-ready, compliant submissions aligned with ICH, GMP, and global CMC guidelines
Apply and refine templates, style guides, and documentation standards
Operate independently, managing timelines and priorities with minimal oversight
Qualification
Required
15–20 years of experience in CMC documentation, regulatory writing, MSAT, or technical operations
Extensive authorship of CMC sections for FDA, EMA, and global submissions
Advanced degree (MS/PhD) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related discipline
Deep understanding of drug substance/drug product manufacturing, control strategies, and lifecycle management
Expert knowledge of ICH guidelines, GMP expectations, and global CMC requirements
Preferred
Experience supporting multi?regional submissions and post?approval changes
Background in process chemistry or pharmaceutical development
Proven success preparing documentation used during regulatory inspections
Experience as a documentation authority within MSAT or Technical Operations
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma 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)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase