Senior Director, Regulatory Affairs

Position

We are seeking an experienced Senior Director, Regulatory Affairs, to lead our regulatory strategy and compliance efforts. In this critical role, you will be responsible for ensuring that our biotechnological innovations align with all relevant regulations and standards. You will collaborate with cross-functional teams to guide product development and market entry strategies while maintaining a steadfast commitment to regulatory integrity and transparency.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

The ideal candidate for this role is a seasoned regulatory professional who possesses in-depth knowledge of FDA and international regulatory requirements and guidelines, coupled with exceptional communication, negotiation, and project management skills. Their proven ability to thrive in a collaborative, cross-functional team environment, along with strong analytical skills, attention to detail, effective problem-solving abilities, and adaptability, makes them well-suited for the position. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.

What You’ll Do

• Regulatory Strategy: Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives.
• Regulatory Compliance: Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements.
• Submission Management: Oversee the preparation, review, and submission of regulatory documents, including but not limited to Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
• Cross-Functional Collaboration: Collaborate closely with R&D, Quality Assurance, Clinical Development, and other teams to provide regulatory guidance and ensure the seamless integration of regulatory considerations into the product development process.
• Quality Assurance: Supervise regulatory aspects of quality systems, including compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP).
• Risk Assessment: Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.

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.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​

• 401k plan with company matching​
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
• Mental health and wellness benefits​
• Weeklong summer and winter holiday shutdowns​
• Generous paid time off and holiday policies​
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
• Enhanced parental leave benefit​
• Daily subsidized lunch program when on-site​

The expected salary range for this role is $239,000 to $261,250 depending on skills, competency, and the market demand for your expertise.