Senior Manager, Regulatory Affairs
J
JobgetherOncology Pharmaceuticals
Remote work arrangement within the United States.Full-TimeManager
SalaryAnnual base salary: $139,800–$184,800
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Job Details
- Experience
- 7+ years
- Required Skills
- GCP
Requirements
- Bachelor’s degree in a relevant discipline.
- 7+ years of related regulatory affairs experience (equivalent professional experience may be considered).
- Demonstrated experience preparing and managing IND submissions, including amendments and supporting documentation.
- NDA experience is strongly preferred.
- Strong knowledge of CTD/eCTD structures and regulatory submission processes.
- Experience publishing documents using Adobe Acrobat Professional or comparable tools.
- Working knowledge of FDA regulations and guidance, as well as applicable ICH requirements.
- Solid understanding of GMP, GLP, and GCP requirements and the pharmaceutical product development lifecycle.
- Strong ability to coordinate complex, cross-functional regulatory projects.
- Excellent written and verbal communication skills.
- Superior planning, organization, prioritization, and attention-to-detail skills.
- Self-motivated and proactive, with sound judgment and the ability to operate effectively in an entrepreneurial, fast-paced environment.
Responsibilities
- Lead and coordinate regulatory activities for assigned development projects across clinical, non-clinical, and CMC functions, ensuring milestones and submissions are delivered accurately and on schedule.
- Develop and implement regulatory strategies and tactics designed to support the earliest possible approvals and clearances for assigned products.
- Manage the preparation, writing, assembly, review, and submission of regulatory dossiers for investigational and registered products in the United States and applicable international markets.
- Lead preparation and submission of INDs, amendments, BLAs/NDAs, supplements, annual reports, safety reports, and other regulatory documentation.
- Prepare and manage regulatory meeting requests and briefing packages, ensuring materials are complete, consistent, and aligned with regulatory strategy.
- Represent Regulatory Affairs on cross-functional project teams, providing regulatory expertise, guidance, and recommendations to support development and business objectives.
- Maintain regulatory submissions and archives in accordance with applicable requirements and internal procedures.
- Monitor regulatory developments and communicate significant changes, risks, and opportunities to relevant stakeholders and management.
- Work effectively with external regulatory consultants, CROs, and other partners when required.
- Support continuous improvement of regulatory processes while maintaining a strong focus on compliance, quality, and timely execution.
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