Director, Regulatory Affairs - Global Labeling
Gilead SciencesSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Clinical ResearchIndustries
Requirements
Candidates must possess a PhD, PharmD, or equivalent experience, with a minimum of 10 years in regulatory affairs within biopharmaceutical companies. This includes 5-7 years in global leadership roles focusing on key regulatory regions such as FDA, EMA, or PMDA. Prior experience in rapidly growing pharmaceutical organizations is desirable. Proficiency in orphan drug development, knowledge of US regulations and evolving guidelines, and experience interacting with regulatory authorities like the FDA and EMA are essential. Well-developed organizational and project management skills are also required.
Responsibilities
The Global Regulatory Lead will develop sound regulatory strategies globally, serve as a key advisor for product launches and commercialization, and provide high-quality guidance on pre-approval, filing, distribution, and post-approval regulatory activities. Responsibilities include providing strategic, operational, and tactical regulatory insight, identifying suitable filing approaches, overseeing regulatory affairs vendors, contributing to regulatory filings (INDs, BLAs, MAAs), managing post-approval activities, monitoring and relaying changes in the global regulatory environment, and acting as a business ally for local commercialization teams. The role also involves partnering with medical, legal, quality, PV, and distribution teams to ensure timely regulatory input.
Skills
Regulatory Strategy
Product Launch
Commercialization
Regulatory Affairs
Clinical Trials
Marketing Authorization
Global Regulatory Affairs
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees