ALKU
Associate Director, Regulatory Affairs
Background:
This is a global regulatory lead position responsible for leading and supporting multiple early phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. This position will report to the Executive Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.
Project:
Lead the preparation and submission of regulatory filings (e.g., NDA, MAA, supplements, variations, IND, CTA, annual reports/progress reports, briefing documents, etc.)
Prepare and coordinate Health Authority interactions
Manage regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
Responsible for the creation and implementation of submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
Work with other regulatory leads to monitor and coordinate timelines of key program activities and the tracking of submission deliverables to maintain target submission dates.
Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines
Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams
Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals
Research and analyze regulatory information and maintain current regulatory knowledge
Ensures day-to-day regulatory requirements are met for their assigned programs and manager (i.e., archiving, submissions)
Required Skills:
Education equivalent to a BS or MS, plus 8 years of hands‑on regulatory experience, or
Education equivalent to a higher degree (PharmD or PhD), plus 6 years of hands‑on regulatory experience,
Knowledgeable in ICH and FDA guidelines relevant to clinical aspects of product development.
Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks
Preferred:
Led or experienced in market application filing (BLA/NDA or supplements/variation with clinical data)
Led a health authority interaction (meeting or primary contact for IND/CTAs)
Preparing/Writing de‑novo regulatory meeting requests/ briefing books
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
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This is a global regulatory lead position responsible for leading and supporting multiple early phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. This position will report to the Executive Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions.
Project:
Lead the preparation and submission of regulatory filings (e.g., NDA, MAA, supplements, variations, IND, CTA, annual reports/progress reports, briefing documents, etc.)
Prepare and coordinate Health Authority interactions
Manage regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications.
Responsible for the creation and implementation of submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions.
Work with other regulatory leads to monitor and coordinate timelines of key program activities and the tracking of submission deliverables to maintain target submission dates.
Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines
Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams
Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals
Research and analyze regulatory information and maintain current regulatory knowledge
Ensures day-to-day regulatory requirements are met for their assigned programs and manager (i.e., archiving, submissions)
Required Skills:
Education equivalent to a BS or MS, plus 8 years of hands‑on regulatory experience, or
Education equivalent to a higher degree (PharmD or PhD), plus 6 years of hands‑on regulatory experience,
Knowledgeable in ICH and FDA guidelines relevant to clinical aspects of product development.
Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks
Preferred:
Led or experienced in market application filing (BLA/NDA or supplements/variation with clinical data)
Led a health authority interaction (meeting or primary contact for IND/CTAs)
Preparing/Writing de‑novo regulatory meeting requests/ briefing books
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
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