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Position

We are seeking a Senior Manager, Regulatory Affairs, to join our dynamic team. In this role, you will play a pivotal part in ensuring that our biotechnological advancements comply with all relevant regulations and standards. You will work closely with cross-functional teams to guide product development and market entry strategies while maintaining compliance and transparency with regulatory agencies.

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 regulatory professional with strong knowledge of FDA and international regulatory requirements and guidelines. Their skill set includes excellent communication, negotiation, and project management skills, with the ability to work effectively in a cross-functional team environment. They possess attention to detail, strong analytical skills, and effective problem-solving abilities, while also demonstrating adaptability to thrive in a fast-paced, high-growth environment. In this role, they will develop and execute regulatory strategies, ensure regulatory compliance, oversee submission management, provide regulatory guidance to cross-functional teams, and act as the primary contact with regulatory agencies for effective communication and negotiation.

What You’ll Do

• Regulatory Strategy: execute regulatory strategies to support product development, approval, and commercialization, ensuring alignment with the company's goals and objectives.
• Regulatory Compliance: Stay current with all relevant regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to applicable regulatory requirements.
• Submission Management: Prepare, review, and submit 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 that regulatory considerations are integrated into product development.
• Quality Assurance: Oversee 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 evaluate regulatory risks associated with projects and provide solutions to mitigate those risks.

Qualifications

• Post Graduate degree with 6+ years of experience or a Bachelor's degree with 8+ years of experience in a relevant scientific discipline.
• Strong knowledge of FDA and international regulatory requirements and guidelines.
• Excellent communication, negotiation, and project management skills.
• Ability to work effectively in a cross-functional team environment.
• Attention to detail, strong analytical skills, and problem-solving abilities.
• Adaptable and able to thrive 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 $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.