Sr. Director, Regulatory Affairs
About The Position
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. 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.
Requirements
- 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.
Responsibilities
- Develop and execute comprehensive regulatory strategies that support product development, approval, and commercialization while aligning with the company's strategic objectives.
- Stay abreast of evolving regulations, guidelines, and industry best practices. Ensure that the company's activities and products adhere to all applicable regulatory requirements.
- 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).
- 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.
- Supervise regulatory aspects of quality systems, including compliance with Good Clinical Practices (GCP), and Good Laboratory Practices.
- Identify and assess regulatory risks associated with projects and proactively propose solutions to mitigate these risks.
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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
