Regulatory Manager jobs in District of Columbia

Now available 6 results are consistent

Sort by:relevance - date

REGULATORY AFFAIRS MANAGER - BIOSIMILARS

Global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans throughout the product lifecycle.. Development of CMC and analytical dossiers required for...

CompanyAmgen
AddressWashington, DC
CategoryInformation Technology
Date Posted 3 days ago See detail

Regulatory Affairs Manager - Biosimilars

Amgen

Washington, DC

Global regulatory CMC activities relevant to the successful execution and implementation of biosimilar CMC regulatory strategies and plans throughout the product lifecycle.. Development of CMC and analytical dossiers required for...

Regulatory Real World Evidence (RWE), Manager

Amgen

Washington, DC

Develop Statistical Analysis plans for observational studies and for studies combining RWD and clinical trial data. Provide support to therapeutic area teams for the design and execution of RWE studies related to regulatory filing...

Regulatory Real World Evidence (RWE), Manager

Biospace

Washington, DC

Develop Statistical Analysis plans for observational studies and for studies combining RWD and clinical trial data. Provide support to therapeutic area teams for the design and execution of RWE studies related to regulatory filing...

Regulatory Writing Senior Manager

Biospace

Washington, DC

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies,...

Regulatory Affairs Manager

Amgen

Washington, DC

Provide Guidance and Leadership on mechanisms to optimize product development and regulatory approvals.. Develops the international regulatory strategy and contributes to global regulatory plans.. Support regulatory product compli...

Regulatory Writing Senior Manager

Biospace

Washington, DC

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies,...