The University of Texas MD Anderson Cancer Center
Senior Manager Regulatory Affairs
The University of Texas MD Anderson Cancer Center, Hayward, California, us, 94557
Job Title:
Senior Manager Regulatory Affairs
Job Number:
88512
Location:
Hayward, US
Job Description:
The Sr. Manager, Regulatory Affairs, is responsible for creating and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory standards. This role supports regulatory submissions across the U.S., APAC, and additional regions, collaborating closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders (consultants, CROs) to drive regulatory success. The position primarily focuses on study-level activities to support overall regulatory goals.
ResponsibilitiesThe Sr. Manager, Regulatory Affairs, manages the preparation, review, and submission of regulatory documents, including INDs, BLAs/NDAs, amendments, supplements, annual reports, and safety reports. Serving as the regulatory lead for study-level management teams, the role involves critically reviewing complex technical documents and collaborating with colleagues across functions to ensure regulatory success. Key responsibilities include providing updates to project teams and senior management on regulatory activities, coordinating responses to health authority queries, and planning and executing regulatory submissions with cross-functional alignment. The Sr. Manager also guides the implementation of new regulatory initiatives to support company goals and ensures timely compilation of all documents needed for regulatory submissions.
Required Skills
Education:
Bachelor’s degree in science or health-related field required; advanced degree is a plus.
Experience:
5+ years in the pharmaceutical or biopharmaceutical industry, with 3+ years in regulatory strategy or relevant experience.
Expertise:
In-depth knowledge of regulatory requirements, including ICH and regional standards, as well as current global and regional trends in regulatory affairs.
Skills:
Experienced with CTD/eCTD and life cycle management. Strong attention to detail and accuracy, with excellent verbal, written, negotiation, and interpersonal communication skills.
Salary:
$160-175k/yr
Application Deadline:
2024-12-16
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Senior Manager Regulatory Affairs
Job Number:
88512
Location:
Hayward, US
Job Description:
The Sr. Manager, Regulatory Affairs, is responsible for creating and managing regulatory strategies to ensure compliance with U.S. FDA and global regulatory standards. This role supports regulatory submissions across the U.S., APAC, and additional regions, collaborating closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders (consultants, CROs) to drive regulatory success. The position primarily focuses on study-level activities to support overall regulatory goals.
ResponsibilitiesThe Sr. Manager, Regulatory Affairs, manages the preparation, review, and submission of regulatory documents, including INDs, BLAs/NDAs, amendments, supplements, annual reports, and safety reports. Serving as the regulatory lead for study-level management teams, the role involves critically reviewing complex technical documents and collaborating with colleagues across functions to ensure regulatory success. Key responsibilities include providing updates to project teams and senior management on regulatory activities, coordinating responses to health authority queries, and planning and executing regulatory submissions with cross-functional alignment. The Sr. Manager also guides the implementation of new regulatory initiatives to support company goals and ensures timely compilation of all documents needed for regulatory submissions.
Required Skills
Education:
Bachelor’s degree in science or health-related field required; advanced degree is a plus.
Experience:
5+ years in the pharmaceutical or biopharmaceutical industry, with 3+ years in regulatory strategy or relevant experience.
Expertise:
In-depth knowledge of regulatory requirements, including ICH and regional standards, as well as current global and regional trends in regulatory affairs.
Skills:
Experienced with CTD/eCTD and life cycle management. Strong attention to detail and accuracy, with excellent verbal, written, negotiation, and interpersonal communication skills.
Salary:
$160-175k/yr
Application Deadline:
2024-12-16
#J-18808-Ljbffr