Gossamer Bio
Exec Director / VP, Regulatory Affairs
Gossamer Bio, San Diego, California, United States, 92189
Summary:
The Exec Dir / VP, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product in a specific indication. The ED/VP is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals.
Essential Duties and Responsibilities:
Develop and implement regulatory strategy for assigned projects.
Act as Regulatory Affairs representative for Project Team.
When assigned, supervise one or more Regulatory Affairs staff, be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.
Serve as the primary interface for FDA on assigned projects.
Communicate project regulatory strategies and plans to management, cross-functional teams, and any partners/collaborators to establish alignment.
Lead the preparation of regulatory submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
Work with functional groups to define contributions for submissions.
Prepare company team for FDA and other health agency meetings, as required.
Serve as the primary interface with CROs for coordination and preparation of Health Authority submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams, and Study Teams.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance, and current industry practices.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Job Qualifications:
Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs.
Experience in multiple phases of development in relevant therapeutic areas. Experience in pulmonary and cardiovascular diseases a plus.
Significant experience in drug development including product approval/launch.
Demonstrated experience in preparing FDA submissions including NDAs or BLAs and experience with global dossiers. Experience with eCTD content and format for regulatory submissions.
Knowledge of the drug development process and global submission process.
Knowledge of global regulatory requirements as they relate to the overall global regulatory strategy.
Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail.
Prior experience with drug/device combination products.
Proven ability to build partnerships with senior key stakeholders from other functions to ensure that the strategic business goals are met through sharing of knowledge and expertise.
Domestic and occasional international travel required (20%).
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state, and local laws governing nondiscrimination in employment.
The expected US salary range for this position is
$245,000 to $320,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental, and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
.
#J-18808-Ljbffr
The Exec Dir / VP, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product in a specific indication. The ED/VP is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals.
Essential Duties and Responsibilities:
Develop and implement regulatory strategy for assigned projects.
Act as Regulatory Affairs representative for Project Team.
When assigned, supervise one or more Regulatory Affairs staff, be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.
Serve as the primary interface for FDA on assigned projects.
Communicate project regulatory strategies and plans to management, cross-functional teams, and any partners/collaborators to establish alignment.
Lead the preparation of regulatory submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc.
Work with functional groups to define contributions for submissions.
Prepare company team for FDA and other health agency meetings, as required.
Serve as the primary interface with CROs for coordination and preparation of Health Authority submissions.
Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams, and Study Teams.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance, and current industry practices.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Job Qualifications:
Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs.
Experience in multiple phases of development in relevant therapeutic areas. Experience in pulmonary and cardiovascular diseases a plus.
Significant experience in drug development including product approval/launch.
Demonstrated experience in preparing FDA submissions including NDAs or BLAs and experience with global dossiers. Experience with eCTD content and format for regulatory submissions.
Knowledge of the drug development process and global submission process.
Knowledge of global regulatory requirements as they relate to the overall global regulatory strategy.
Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail.
Prior experience with drug/device combination products.
Proven ability to build partnerships with senior key stakeholders from other functions to ensure that the strategic business goals are met through sharing of knowledge and expertise.
Domestic and occasional international travel required (20%).
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state, and local laws governing nondiscrimination in employment.
The expected US salary range for this position is
$245,000 to $320,000 . Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental, and vision insurance, 401(k) and 401(k) matching, long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal, and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit
https://www.gossamerbio.com/work-at-gossamerbio/
.
#J-18808-Ljbffr