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 regulatory response teams for FDA and Health Canada questions. Manage routine maintenance submissions, coordinate NA post-approval commitments, and approve submissions before dispatch to regulatory authorities. Develop, execute, and maintain submission delivery plans while providing strategic input to clinical protocols and nonclinical reports. Collaborate with cross-functional teams to lead Health Authority interactions and ensure labeling consistency with CCDS. This role supports initiatives for the Interventional Oncology group within Johnson & Johnson's Innovative Medicine, offering flexibility across pharma, devices, and combo products.
Required Qualifications
- 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
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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