Product Development Associate
Product Development Specialist-
The incumbent will assist with CMC product development activities and create, edit, review and collate product development and regulatory documentation. Documentation will include manufacturing and analytical validation protocols/reports, Product Development Reports, stability protocols/reports and data summaries. Regulatory writing will include technical sections of Module 3 CDT sections with emphasis on manufacturing process and analytical method narratives.
The incumbent will work with subject matter experts and key team members to ensure timely development and accurate content of required documentation that Regulatory will submit to relevant regulatory authorities to support animal drug applications for a broad range of dosage types.
Qualifications include a degree in life sciences or physical sciences with broad experience in formulation development/analytical methods/manufacturing in a pharmaceutical setting. Previous experience with CMC technical writing and the ability to prepare CMC/regulatory documentation with significant independence is preferred. Working knowledge of cGMP’s and CTD format, excellent verbal and written communication skills and collaboration skills with focus on timely delivery are critical. The successful candidate will have 3+ years of experience in the pharmaceutical industry. Working knowledge of Microsoft Office and Adobe are essential. Other requirements include the ability to analyze document sets and developing strategies and tactics for improvements is highly desirable. Having the ability to standardize numerous technical data sets into a clear concise narrative is essential.
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