Aldevron
Senior Director Global Regulatory Affairs
Aldevron, Fargo, Georgia, United States,
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or you are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance with global regulations and standards across multiple markets. You will collaborate closely with quality, operations, and regulatory authorities to navigate complex regulatory environments and drive successful product registrations and approvals.
In this role, you will have the opportunity to:
Lead regulatory submissions, including pre-market applications, product registrations, post-approval updates, by ensuring accuracy, completeness, and timeliness.
Monitor and interpret global regulatory requirements and trends, provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities.
Oversee regulatory submission activities including the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc.
Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial services.
Provide regulatory expertise and guidance to internal teams, including commercial, R&D, quality, clinical, and marketing, throughout the drug product cycle.
Responsible for the qualification and management of vendors and maintaining the approved supplier list.
Lead and manage a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.
The essential requirements of the job include:
Bachelor's degree in a relevant scientific discipline; at least 12+ years of relevant experience in a QRA position supporting drug product commercialization required, with a minimum of 3 years in managing a team.
Experience leading regulatory submissions and interactions with regulatory authorities in different countries.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application.
Strong leadership and management skills, with a track record of building and developing high-performing teams.
Excellent analytical, problem-solving, and decision-making abilities; strong written and verbal communication skills.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel 25% to Fargo, ND along with other Aldevron sites, meetings, and/or client locations as business needs require.
Additional Information:
At Aldevron we believe in designing a better, more sustainable workforce. This position is eligible for a remote work arrangement. The salary range for this role is $150,000 - $170,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay and we offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology.
#J-18808-Ljbffr
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of Quality and Regulatory Affairs located in Fargo, ND and will be fully remote. You will lead the Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance with global regulations and standards across multiple markets. You will collaborate closely with quality, operations, and regulatory authorities to navigate complex regulatory environments and drive successful product registrations and approvals.
In this role, you will have the opportunity to:
Lead regulatory submissions, including pre-market applications, product registrations, post-approval updates, by ensuring accuracy, completeness, and timeliness.
Monitor and interpret global regulatory requirements and trends, provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities.
Oversee regulatory submission activities including the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc.
Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial services.
Provide regulatory expertise and guidance to internal teams, including commercial, R&D, quality, clinical, and marketing, throughout the drug product cycle.
Responsible for the qualification and management of vendors and maintaining the approved supplier list.
Lead and manage a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.
The essential requirements of the job include:
Bachelor's degree in a relevant scientific discipline; at least 12+ years of relevant experience in a QRA position supporting drug product commercialization required, with a minimum of 3 years in managing a team.
Experience leading regulatory submissions and interactions with regulatory authorities in different countries.
Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application.
Strong leadership and management skills, with a track record of building and developing high-performing teams.
Excellent analytical, problem-solving, and decision-making abilities; strong written and verbal communication skills.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel 25% to Fargo, ND along with other Aldevron sites, meetings, and/or client locations as business needs require.
Additional Information:
At Aldevron we believe in designing a better, more sustainable workforce. This position is eligible for a remote work arrangement. The salary range for this role is $150,000 - $170,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This job is also eligible for bonus/incentive pay and we offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology.
#J-18808-Ljbffr