Eikontherapeutics
Sr. Director, Regulatory Affairs
Jersey City, NJ. Posted 3 months ago
The role
The Senior Director, Regulatory Affairs will lead regulatory strategy and compliance efforts. This person will develop regulatory strategies, manage submissions, and collaborate with cross-functional teams to guide product development and market entry.
What you will do
- Develop and execute comprehensive regulatory strategies
- Stay abreast of evolving regulations, guidelines, and industry best practices
- Ensure company activities and products adhere to all applicable regulatory requirements
- Oversee the preparation, review, and submission of regulatory documents including IND, NDA, and MAA
- Collaborate with R&D, Quality Assurance, Clinical Development, and other teams
- Supervise regulatory aspects of quality systems including compliance with GCP and GLP
- Identify and assess regulatory risks and propose solutions to mitigate them
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
- Effective problem-solving abilities
- Adaptability and the ability to excel in a fast-paced, high-growth environment
Benefits
- 401k plan with company matching
- Medical insurance (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%)
- Optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
About the company
Eikon Therapeutics is a biopharmaceutical company using technology at the intersection of chemistry, engineering, computation, and biology to discover treatments for life-threatening diseases. The company's discovery platform is built on innovations from its founders.