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.
Please note that starting April 2025, Eikon Hayward positions will be moving to our new headquarters in Millbrae, CA
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.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
What We Do
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the interface of biology, engineering and chemistry 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.
By directly measuring the effects of chemical compounds on the behavior of protein molecules in a live cellular environment, Eikon’s landmark assays facilitate the highly sensitive identification of compound-protein interactions that could not be identified through traditional assays, thereby unlocking otherwise intractable classes of proteins as drug targets. Furthermore, the ability to directly visualize protein mechanisms in disease coupled with the extraordinarily high-powered high-content data sets generated by Eikon’s drug-screening technology enable an unprecedented opportunity to quantitatively explore novel biology in the living cell. These insights facilitate creation and application of data-driven hypotheses to the discovery of life-saving therapies.
Eikon is seeking adventurous, passionate and creative team members eager to apply their talents to empower interdisciplinary scientific exploration, inaugurate a radical drug-discovery paradigm, and ultimately create novel medicines. To learn more about open positions, please visit: https://eikontx.com/team#positions
