Senior Manager, Regulatory Affairs
Hybrid Role - Menlo Park, CA*
Meet has partnered with an exceptional Bay Area pharma focused in treatments for metabolic, psychiatric, and oncologic disorders.
Our client has an approved product and a dynamic late-stage pipeline. They are looking for a Senior Manager of Regulatory Affairs to join their team and support their neurology and endocrinology programs.
Key Responsibilities
- Manage the preparation of Regulatory filings (IND, CTA, NDA, MAA) and author sections of those documents as needed
- Maintain up-to-date knowledge of US and ex-US health authority requirements
- Provide support to health authority interactions
- Provide input and execute long-term regulatory strategy for assigned programs
Key Qualifications
- 5+ years of Regulatory Affairs experience
- Neurology / Endocrinology experience preferred
- Experience supporting programs from P1-P3
- Small molecule background preferred
Please reach out to Ryan Moran to learn more :
ryan.moran@peoplewithchemistry.com
Senior Business Affairs Manager
A company is looking for a Senior Business Affairs Manager. Key Responsibilities:Manage contracts, bid reviews, and track music costsReview content for risk and clearance concernsOversee talent agreements, payments, and job closuresRequired Qualifications:8+ years of relevant agency/business affairs...
Senior Manager of Money Compliance, Regulatory
Manager, Regulatory Compliance will be the primary point of contact for Robinhood's money transmitter and credit card product regulators, and report directly to the Chief Compliance Officer for Robinhood Money, LLC and Robinhood Credit, Inc. You will be responsible for ensuring Robinhood embeds regu...
Senior Director Global Regulatory Affairs
Postgraduate degree in Regulatory Affairs preferredMinimum 10+ years of regulatory experience in biotech or pharmaceutical industryPrevious oncology experience highly preferredMinimum of 7 years regulatory experience in drug development and approval process. A company is looking for a Senior Directo...
Senior Regulatory Compliance Assurance Testing Program Manager (Leading FinTech)
Working as a member of Intuit's Legal, Compliance & Policy Organization (LCPO, you will be responsible for ensuring client meets important regulatory compliance requirements by completing testing and by partnering cross-functionally to implement and manage innovative solutions for continuous com...
Senior Director, Regulatory Affairs
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affair...
Senior Director, CMC Regulatory Affairs – Biologics Project Lead
The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team of professionals, who work with a specific product in Gilead’s global portfolio of biological products in CMC Regulatory Affairs. Lead the execution of these global CMC regulatory plans, including over...
Vice President/Senior Vice President, Regulatory Affairs
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
PLS Regulatory Senior Manager
The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters. Ab...
Senior Regulatory Affairs Specialist - Vascular (on-site)
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Senior Regulatory Affairs Specialist. Assist in the development of regional regulatory strate...
Senior Specialist, Regulatory Affairs, Critical Care
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...