Senior Manager Regulatory Affairs (contract)

ESSENTIAL DUTIES & RESPONSIBILITIES

• Serve as the Regulatory Affairs representative for Phase 1 to Phase3 trials, ensuring regulatory activities are evaluated, prioritized and executed to meet global regulatory requirements.
• Serve as the Regulatory Affairs representative on assigned study teams and assure the progress of studies by addressing regulatory related queries in support of regulatory approvals.
• Lead preparation, review and submission of INDs/CTAs, amendments, review and approval of investigator document packages and manage other regulatory activities of the assigned studies as needed.
• Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for Phase 1 to 3 trials.
• Interact with Contract Research Organization (CRO) Regulatory Affairs counterpart.
• Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.

EDUCATION/EXPERIENCE/SKILLS

• Bachelor’s or advanced degree in scientific discipline, with a minimum of 5 years of experience working in drug development in the biopharmaceutical industry and at least 3 years of experience in Regulatory Affairs; immunology or rare disease/orphan drug development experience desirable.
• Direct experience with pharmaceutical global regulatory submissions and contributing to major regulatory filing(s) such as IND/CTA.
• Working knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
• Demonstrated experience in successfully leading assigned activities within cross-functional teams.
• Excellent verbal and written communication skills.
• Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
• Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others, prior management experience a plus.