San Diego, CA
Manager, Regulatory Affairs - CMC
General Job Description:
Write/edit and manage Chemistry, Manufacturing, and Controls (CMC) submissions to advance drug candidates and maintain commercial products including small molecule parenteral drug products and combination drug-device products.
Assist in developing and planning regulatory CMC submissions including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs) based on regulatory guidance, regulations, and directives.
Develop timelines for CMC submissions and follow up with subject matter experts (CMC, Regulatory Operations, QC) to ensure timely and quality submissions. Proactively work to resolve issues, as appropriate.
Provide CMC regulatory advice to manufacturing, quality control, and pharmaceutical sciences based on current regulatory guidance’s.
6-8 years of pharmaceutical industry experience in a CMC discipline; ideally with a minimum of 2-3 years in CMC regulatory.
Experience in preparing/reviewing regulatory IND/CTA and NDA/MAA submissions and electronic Common Technical Document eCTD preparation.
Proven ability to effectively work on interdisciplinary and cross functional teams.
Experience working with contact research and manufacturing organizations.
Strong attention to detail required.
Strong written and verbal communication skills required.
Strong computer skills required including experience with MS Word templates, MS Project or similar planning tools, and electronic document management systems (eg, Documentum, VEEVA).
Application Information & Contact (How to Apply)
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Learn more about Heron Therapeutics at www.herontx.com