Gossamer Bio
Director / Senior Director, CMC Regulatory Affairs
Gossamer Bio, San Diego, California, United States, 92189
Summary:
The Director / Sr. Director, Regulatory Affairs will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product. In this hands-on role, s/he will provide dynamic leadership and direction to multi-disciplined project teams and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also support and provide key contributions to department and company initiatives related to regulatory affairs operations and strategy.
Key Responsibilities
Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals as assigned, including regulatory strategy development.
Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks.
Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape. Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
Evaluate proposed CMC changes for global impact and provide sound regulatory strategies that support compliant change implementation.
Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, NDA/MAA, pre-meeting briefing documents, etc.).
Serve as the primary interface for FDA on assigned projects.
Prepare and lead teams through successful regulatory meetings and interactions.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice as it relates to pharmaceutical development and quality.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Participate in Business Development efforts, as assigned.
Experience & Education
Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 10 years pharmaceutical industry experience, including 5-7 years in CMC Regulatory Affairs. Global experience desired.
Good understanding and knowledge of small molecule manufacturing and analytical methods is desired.
Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
Knowledge of global regulatory regulations and guidances 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.
Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
Domestic and occasional International travel may be necessary.
This position can be based remotely within the United States or Hybrid from our Dublin, Ireland office.
Equal Opportunity Employer
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.
Salary and Benefits
The expected US salary range for this position is
$200,000 to $240,000 . 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 Director / Sr. Director, Regulatory Affairs will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination product. In this hands-on role, s/he will provide dynamic leadership and direction to multi-disciplined project teams and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also support and provide key contributions to department and company initiatives related to regulatory affairs operations and strategy.
Key Responsibilities
Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones/goals as assigned, including regulatory strategy development.
Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks.
Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and stay abreast of the regulatory landscape. Assume a global view of CMC regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
Evaluate proposed CMC changes for global impact and provide sound regulatory strategies that support compliant change implementation.
Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, NDA/MAA, pre-meeting briefing documents, etc.).
Serve as the primary interface for FDA on assigned projects.
Prepare and lead teams through successful regulatory meetings and interactions.
Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances, and current industry practice as it relates to pharmaceutical development and quality.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Participate in Business Development efforts, as assigned.
Experience & Education
Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 10 years pharmaceutical industry experience, including 5-7 years in CMC Regulatory Affairs. Global experience desired.
Good understanding and knowledge of small molecule manufacturing and analytical methods is desired.
Extensive experience working on development programs and driving regulatory strategies specifically relating to the CMC aspects of the project.
Knowledge of global regulatory regulations and guidances 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.
Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
Domestic and occasional International travel may be necessary.
This position can be based remotely within the United States or Hybrid from our Dublin, Ireland office.
Equal Opportunity Employer
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.
Salary and Benefits
The expected US salary range for this position is
$200,000 to $240,000 . 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