Address
Form of workResponsibilities and Duties:
- 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
Required 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
Bonus Qualifications:
- Understanding of Orphan Drug regulations
- Experience leading HA interactions
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