The University of Texas MD Anderson Cancer Center
Sr. Director, Regulatory Affairs
The University of Texas MD Anderson Cancer Center, San Diego, California, United States, 92189
Job Title: Sr. Director, Regulatory Affairs
Job Number:
88521
Location:
San Diego,US
Job Description
$250-320K Onsite/Hybrid in San Diego Regulatory Operations
The Senior Director Regulatory Affairs is responsible for developing and
executing a consolidated regulatory strategy to ensure market access for
assigned products in specific indications. This role requires leadership in
establishing and maintaining strong relationships with regulatory agencies,
especially the FDA, and managing a team responsible for preparing regulatory
submissions. As a core project team member, the Senior Director collaborates
with cross-functional teams and regulatory bodies to secure and maintain
product approvals.
ResponsibilitiesEssential Duties and Responsibilities:
* Develop and implement regulatory strategy for assigned projects.
* Lead regulatory affairs efforts for project teams and supervise regulatory
staff.
* Serve as the primary liaison with the FDA and other regulatory agencies.
* Communicate regulatory strategies to management, cross-functional teams,
and partners.
* Lead preparation of regulatory submissions, including INDs, Briefing
Documents, Orphan Drug Applications, and Marketing Applications.
* Collaborate with functional groups to define submission contributions.
* Prepare the company team for meetings with health authorities.
* Coordinate with CROs for Health Authority submissions.
* Represent Regulatory Affairs in cross-functional teams.
* Stay informed on global regulatory trends, competitive landscapes, and
industry practices.
* Contribute to the development and maintenance of regulatory processes and
procedures.
Required SkillsQualifications:
* Education: Bachelor’s degree in a scientific discipline; advanced degree
preferred.
* Experience: 15+ years in the pharmaceutical industry, including 10+ years
in Regulatory Affairs. Experience in pulmonary and cardiovascular diseases is a
plus.
* Expertise: Extensive experience in drug development, including product
approval/launch and preparing FDA submissions (NDAs/BLAs). Familiar with global
submission processes, eCTD content, and regulatory requirements.
* Skills: Strong organizational, communication, and time management skills.
Ability to lead teams, innovate, and solve problems independently. Experience
with drug/device combination products and building partnerships across
functions to meet business goals.
* Travel: Domestic and occasional international travel (up to 20%).
Application Deadline:
2024-12-16
#J-18808-Ljbffr
Job Number:
88521
Location:
San Diego,US
Job Description
$250-320K Onsite/Hybrid in San Diego Regulatory Operations
The Senior Director Regulatory Affairs is responsible for developing and
executing a consolidated regulatory strategy to ensure market access for
assigned products in specific indications. This role requires leadership in
establishing and maintaining strong relationships with regulatory agencies,
especially the FDA, and managing a team responsible for preparing regulatory
submissions. As a core project team member, the Senior Director collaborates
with cross-functional teams and regulatory bodies to secure and maintain
product approvals.
ResponsibilitiesEssential Duties and Responsibilities:
* Develop and implement regulatory strategy for assigned projects.
* Lead regulatory affairs efforts for project teams and supervise regulatory
staff.
* Serve as the primary liaison with the FDA and other regulatory agencies.
* Communicate regulatory strategies to management, cross-functional teams,
and partners.
* Lead preparation of regulatory submissions, including INDs, Briefing
Documents, Orphan Drug Applications, and Marketing Applications.
* Collaborate with functional groups to define submission contributions.
* Prepare the company team for meetings with health authorities.
* Coordinate with CROs for Health Authority submissions.
* Represent Regulatory Affairs in cross-functional teams.
* Stay informed on global regulatory trends, competitive landscapes, and
industry practices.
* Contribute to the development and maintenance of regulatory processes and
procedures.
Required SkillsQualifications:
* Education: Bachelor’s degree in a scientific discipline; advanced degree
preferred.
* Experience: 15+ years in the pharmaceutical industry, including 10+ years
in Regulatory Affairs. Experience in pulmonary and cardiovascular diseases is a
plus.
* Expertise: Extensive experience in drug development, including product
approval/launch and preparing FDA submissions (NDAs/BLAs). Familiar with global
submission processes, eCTD content, and regulatory requirements.
* Skills: Strong organizational, communication, and time management skills.
Ability to lead teams, innovate, and solve problems independently. Experience
with drug/device combination products and building partnerships across
functions to meet business goals.
* Travel: Domestic and occasional international travel (up to 20%).
Application Deadline:
2024-12-16
#J-18808-Ljbffr