Sr. Director, Regulatory Affairs
$235,000–$288,750 year
On-siteJersey City, New Jersey, United States
Job Summary
Develop and execute comprehensive regulatory strategies supporting product development, approval, and commercialization while ensuring alignment with FDA and international requirements. Oversee the preparation, review, and submission of regulatory documents including IND applications, NDAs, and MAAs. Collaborate with R&D, Quality Assurance, and Clinical Development teams to integrate regulatory considerations into the product lifecycle, supervise quality systems under GCP and GLP, and assess risks to propose mitigation solutions. Maintain adherence to evolving guidelines and industry best practices. Requires 3+ days onsite in Jersey City (NJ) with a salary range of $235,000 to $288,750.
Required Qualifications
- Post Graduate degree with 12+ years of experience or a Bachelor's degree with 15+ years of relevant experience
- In-depth knowledge of FDA and international regulatory requirements and guidelines
- Exceptional communication, negotiation, and project management skills
- Proven ability to thrive in a collaborative, cross-functional team environment
- Strong analytical skills, attention to detail, and effective problem-solving abilities
- Adaptability and the ability to excel in a fast-paced, high-growth environment
- Minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office
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