CMC Regulatory Technical Writer - United States
This position requires the incumbent to be highly organized, self-motivated, and able to juggle multiple priorities. The desired candidate will have the capacity to be productive with very little supervision and enjoy writing. Excellent interpersonal communication skills are required. Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired.
The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality Investigations with a demonstrated ability to interact with a multi-disciplined team. Experience with standardized templates and familiarity with US and International regulatory submissions is desired. The ability to communicate using oral and written skills with an excellent knowledge of the English language and strong proofreading and spelling skills is required.
Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF annual updates for assigned products in eCTD format. Work closely with quality, manufacturing, regulatory and technical staff from global locations and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities.
Contribute to various projects by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations. Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports. Recommend table of contents for regulatory submissions. Develop and contribute to regulatory strategy for successful product registration. Provide and write answers to questions received from health authorities. Create and author dossiers for re-registrations. Ensure all dossiers are in compliance with appropriate SOPs, guidance's, GXP and ICH guidance's and maintain up to date knowledge. Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions. Develop and maintain skills required for dossier related software systems used and included in regulatory filings
3 plus years' experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities. BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
Experienced with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for submissions.
Worked with multi-disciplined teams in the bio-pharmaceutical industry and with internal and external partners.
Excellent technical writing and communication skills, attention to detail and formatting. Inform management in advance of barriers to meeting deadlines.
In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR). Working knowledge of cGMP's
Worked with writing template tools, Documentum based or similar systems