Senior Director Regulatory Strategy
Senior Director Regulatory Strategy
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Seeking an experienced regulatory affairs leader to manage and direct regulatory activities for assigned commercial and/or development-stage products. This role is accountable for ensuring alignment and compliance with local and regional registration requirements as well as internal policies and procedures. You will oversee the development and execution of global regulatory strategies ensure timely preparation review and submission of documentation to regulatory authorities collaborate with development partners and drive compliance with applicable requirements. The position provides leadership and guidance to program teams on regulatory requirements processes and logistics to support global drug development from preclinical stages through marketing applications and lifecycle management.
Key Responsibilities (include but are not limited to):
Provide regulatory leadership for one or more development projects including global regulatory strategy IND/CTA/NDA/MAA submissions application maintenance updates and preparation for key milestone meetings with regulatory agencies.
Author and oversee various submission documents meeting requests and briefing packages; coordinate and prepare teams for health authority interactions.
Develop and implement regulatory strategies to secure the earliest possible marketing approvals from global regulatory bodies.
Provide strategic oversight on global regulatory requirements advising management and project teams on regulatory issues for the planning compilation and submission of IND/CTA and NDA/MAA applications.
For commercial products deliver regulatory guidance on lifecycle management including label development safety-related label changes and ongoing regulatory oversight.
Serve as the primary regulatory contact with health authorities for assigned programs and/or oversee designated health authority interactions.
Lead the global regulatory subteam for assigned projects overseeing dossier filing plans and regulatory activity timelines.
Critically review all documentation supporting regulatory applications to ensure compliance with internal data standards and submission requirements.
Advise senior management on regulatory strategies procedures and best practices.
Address complex regulatory issues offering advanced solutions and guidance to cross-functional teams.
Partner with key stakeholders to enable science-based regulatory decision-making.
Act as the strategic regulatory liaison with partner organizations.
Conduct due diligence activities as the regulatory expert for assigned projects.
Lead continuous improvement initiatives within the regulatory function making recommendations in areas of expertise.
Perform other duties as assigned.
Requirements:
BS/BA degree in life sciences or related field and 15 years of experience in the pharmaceutical industry including drug development experience with proven success in regulatory submission strategy execution and health authority interactions. Prior US marketing application filing experience preferred; ex-US experience strongly preferred.
OR Master s degree in life sciences or related field and 13 years of related experience.
OR PhD in life sciences or related field and 10 years of related experience.
Extensive prior managerial experience required.
Demonstrated expertise in writing and leading regulatory documents (e.g. meeting requests briefing books) and overseeing submission processes.
Employment Type
Full Time
