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Regulatory Affairs Manager
A company is looking for a Regulatory Affairs Manager to oversee global regulatory activities and collaborate with cross-functional teams. Key Responsibilities Support the Global Regulatory Lead in developing and implementing US labeling Interface with Regulatory Operations and CROs for submissions to Health Authorities Assist in major submissions related to IND and NDA/BLA applications Required Qualifications PhD or PharmD with 2+ years, MS with 4+ years, or BS with 5+ years of regulatory affairs experience Knowledge of applicable regulations and experience in interpretation of guidelines Strong operational skills including planning and organizing Ability to work independently and collaboratively within cross-functional teams Experience in building relationships and generating innovative solutions
A company is looking for a Regulatory Affairs Manager to oversee global regulatory activities and collaborate with cross-functional teams.
Key Responsibilities
Support the Global Regulatory Lead in developing and implementing US labeling
Interface with Regulatory Operations and CROs for submissions to Health Authorities
Assist in major submissions related to IND and NDA/BLA applications
Required Qualifications
PhD or PharmD with 2+ years, MS with 4+ years, or BS with 5+ years of regulatory affairs experience
Knowledge of applicable regulations and experience in interpretation of guidelines
Strong operational skills including planning and organizing
Ability to work independently and collaboratively within cross-functional teams
Experience in building relationships and generating innovative solutions