Provide strategic regulatory direction and write/edit/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.
ESSENTIAL DUTIES & RESPONSIBILITIES:
Develop and plan regulatory CMC submissions including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), meeting requests, briefing materials, and information requests 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 and gain agreement, as appropriate.
Provide CMC regulatory advice to manufacturing, quality control, and pharmaceutical sciences based on current regulatory guidances.
Serve as regulatory CMC representative on project team(s).
Provide detailed regulatory assessments for commercial product(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 lead and work with interdisciplinary and cross functional teams.
Experience working with contract 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).
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
Internal Number: 6
About Heron Therapeutics
Our mission is to improve the lives of patients by developing novel, best-in-class treatments to address some of the most important unmet patient needs. We aim to develop patient-focused solutions by applying our innovative science and technologies with well-known pharmacology.
Our product portfolio includes the following:
SUSTOL® (granisetron) extended-release injection is approved by the U.S. Food and Drug Administration (FDA) and is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.
CINVANTI® (aprepitant) injectable emulsion, for intravenous use is approved by the FDA and is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin and nausea and vomiting associated with initial and repeat courses of modera...tely emetogenic cancer chemotherapy (MEC).
HTX-011 is our long-acting formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the prevention of post-operative pain. Targeting both pain and inflammation has allowed HTX-011 to demonstrate an advantage over current standard of care in multiple surgical models-bunionectomy, hernia repair and abdominoplasty (tummy tuck)-in Phase 2 studies. Recently, Heron initiated patient enrollment in its Phase 3 program and anticipates completing the Phase 3 program in the first half of 2018. Heron expects to file an NDA for HTX-011 in 2018.
SUSTOL, CINVANTI, and our investigational product candidates utilize our innovative science and technology platforms, including our proprietary Biochronomer® drug delivery technology, which can deliver therapeutic levels of a wide range of otherwise short-acting pharmacological agents over a period of days to weeks with a single injection.