Sr. Director, Regulatory Affairs

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.

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 Clinical Practices (GCP), and Good Laboratory Practices.
• 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.

Benefits

• 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

Pay

The expected salary range for this role is $235,000 to $288,750 depending on skills, competency, and the market demand for your expertise.