Director, Regulatory Affairs - Global Labeling
Gilead SciencesSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
Candidates must possess a Bachelor's degree in life sciences, with an advanced degree being preferred. A minimum of 5 years of experience in the biotech/pharmaceutical industry is required, including at least 4 years in CMC regulatory affairs, ideally within cell therapies. Proficiency in cGMP, domestic and global CMC regulatory requirements, and strong scientific writing skills, particularly for high-quality regulatory packages like BLAs, are essential. The ability to collaborate effectively in cross-functional teams, manage multiple tasks independently, and utilize computer applications such as MS Project, Office suite, and Smartsheet is also necessary.
Responsibilities
The Manager, Regulatory CMC will lead the authoring and preparation of regulatory packages for CMC development, including meeting packages for global regulatory interactions. This role involves developing and reviewing content for Mod 3 and assisting with Mod 2.3 for BLA/MAA filings, as well as supporting the development of CMC regulatory strategies for all stages of product development. Responsibilities include working with cross-functional teams to align regulatory packages with development objectives and timelines, identifying and mitigating regulatory risks, and monitoring agency activities. The position also entails evaluating proposed manufacturing changes for global impact, contributing to strategic regulatory plans, and acting as a CMC Regulatory representative on project teams to support milestones and ensure compliance with current regulatory requirements and guidance.
Skills
Regulatory CMC
cGMP manufacturing
analytical practices
regulatory guidelines
BLA
MAA
Mod 3
Mod 2.3
post-market
cell therapies
Orca Bio
Develops and commercializes cell therapies
About Orca Bio
Orca Bio operates in the biotechnology sector, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company works to enhance these therapies, aiming to make them safer and more effective for patients. Orca Bio's products are primarily used by healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to improve patient outcomes through advanced cell therapies, addressing conditions that currently have limited treatment options.
Menlo Park, CaliforniaHeadquarters
2016Year Founded
$186.8MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees