Associate Director, Regulatory Affairs, North American Regional Leader
$137,000–$235,750 year
On-siteRaritan, New Jersey, United States or Spring House, Pennsylvania, United States
Job Summary
Establish North American content requirements and timing for global dossier plans including BLA/NDAs, IND/CTAs, and supplements. Serve as primary point of contact for US FDA and lead the regulatory response team for FDA and Health Canada questions. Drive regulatory submission strategy, identify risks and opportunities, and manage procedures through approvals while coordinating post-approval commitments. Develop and execute submission delivery plans, review USPI and NA labelling negotiation strategies, and ensure consistency with CCDS annotations. Provide strategic regulatory input to clinical protocols, reports, and summary documents, collaborating with cross-functional teams on oncology therapeutic area projects. This role includes 10% domestic travel and potential international travel, with a hybrid work schedule.
Required Qualifications
- Minimum of a Bachelor's degree in scientific or equivalent discipline
- Bachelor's degree plus 8+ years relevant experience
- Master's degree/ PharmD plus 6+ years relevant experience
- PhD plus 4+ years relevant experience
- Relevant regulatory experience and understanding of clinical drug development
- Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions
- Experience in lifecycle management of IND/NDA and other regulatory submissions
- Demonstrated experience in critically reviewing and compiling regulatory documents
- 10% domestic travel and potential international travel
- Bachelor's degree, English major preferred
Desired Qualifications
- Oncology experience
- Diverse therapeutic area experience
- Experience with companion diagnostics, combination products and/or biomarker development
- Experience with medical device
- Proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization
- The ability to effectively prioritize assignments for multiple products and projects simultaneously
- Strong interpersonal and communication skills
- Experience people management/coaching/mentoring
- Leadership capabilities and ability to work successfully in a matrixed environment
- Exercises strong organizational and time management skills
- Exercises independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions
- Demonstrated ability of strategic thinking and contingency planning with respect corporate objectives
- Effective critical thinking including problem solving and goal setting for improved efficiencies
- Strong collaboration skills, including effective communication and conflict resolution skills
- May cultivate and leverage strategic networks and partnerships
- Analytical Reasoning
- Business Writing
- Compliance Risk
- Fact-Based Decision Making
- Industry Analysis
- Legal Support
- Mentorship
- Organizing
- Product Licensing
- Public Policies
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Risk Assessments
- Strategic Thinking
- Technical Credibility
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