Sr Manager/AD Regulatory Affairs (small molecules)

Job Description

• Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictions • Oversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissions • Conduct regulatory review of submission documents • Coordinate with external publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring conformance with submission standards • Represent Regulatory Affairs on cross-functional study teams and provide regulatory guidance • Regulatory point of contact for preparation of IND annual reports/DSUR and contribute to authoring • Prepare and review IND amendments (e.g. monthly clinical site packages) • Responsible for compliant regulatory archives by logging, tracking, and filing of submissions and correspondence with regulatory authorities • Lead meeting request and briefing book development for some Health Authority (HA) meetings • Lead team preparation for some milestone HA meetings • Support the selection and onboarding of vendors/CRO’s and provide effective ongoing management to vendors/CRO’s to ensure compliance and execution of deliverables • Develop and maintain regulatory knowledge and advise on changing regulatory requirements • Track and execute on commitments from Regulatory Agency submissions and/or Agency Feedback • Manage the development regulatory SOPs

Qualifications

• University degree in biology, biochemistry, immunology, microbiology, biotechnology, or similar disciplines • Five to eight or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Senior Manager level; Eight to ten or more years of experience in Regulatory Affairs in the pharmaceutical industry for the Associate Director level • Experience working on IND submissions • Experience contributing and attending HA meetings • Familiar with FDA regulations and FDA/ICH guidelines • Working knowledge of regulatory compliance for essential clinical site documents and proven practical experience in preparing investigator information for FDA submission. • Experience with ex-US regulations and practical experience in preparing CTAs • Meticulous attention to detail • Ability to self-manage varying workloads across several programs • Strong interpersonal and communication skills

Benefits

• 11 paid holidays • Generous Accrued Time Off increasing with years of service • Generous paid sick time • Annual day of service