Manager, Regulatory Affairs

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.

Position

We are seeking a highly motivated regulatory manager for our global organization. The successful candidate will be responsible for successfully filing all submissions and ensuring that all submissions are completed accurately and efficiently in compliance with regulatory requirements. The Manager will also work closely with cross-functional teams, including regulatory affairs operation, clinical operations, quality assurance, and medical affairs, to ensure the timely and effective delivery of regulatory submissions.

About You

You are recognized as an expert resource on a range of Regulatory Submission topics and you have superior oral and written communication and leadership skills in an international environment, coupled with excellent organizational and project management skills.

What You'll Do

• Manage the regulatory submission process for our global organization, including planning, organizing, and coordinating and QCing submission activities to ensure the accuracy, timely and efficient submission of regulatory documents to global health authorities.


• Ensure that all regulatory submissions are completed accurately, on time, and in compliance with regulatory requirements.


• Provide leadership and guidance to the submission management team, setting clear objectives, and expectations to ensure high-quality work and continuous improvement.


• Ensure the timely and effective delivery of regulatory submissions by collaborating with cross-functional teams, including regulatory affairs, clinical operations, quality assurance, and medical affairs.


• Manage relationships with external partners, including contract research organizations, to ensure efficient and effective submission management.


• Keep up to date with changes in regulatory requirements and industry trends, providing guidance and recommendations to the regulatory affairs team on the impact of such changes on the submission management process.


• Develop and maintain standard operating procedures for submission management to ensure consistency, efficiency, and compliance across the organization.


• Define scope, and deliverables to be generated to ensure comprehensive filings for FDA review


• Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.


• Prepare, review and approves regulatory submissions (i.e amendments, INDs etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance.


• Support preparation meetings for FDA and response to questions meetings.


• Interacts with various departments as needed on regulatory issues and/or strategy.


• Maintains awareness of all regulatory activities on assigned projects.

Qualifications

• Bachelor's degree in a scientific discipline or related field


• At least 4 years of experience in regulatory affairs, with a focus in a global setting.


• Proven track record of managing and leading submission management teams.


• Strong knowledge of global regulatory requirements, including FDA and EMA guidelines, and experience in preparing regulatory submissions for these agencies.


• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external partners.


• Strong project management skills, with the ability to manage multiple projects and priorities simultaneously.


• Strong analytical and problem-solving skills, with the ability to identify issues and develop effective solutions.


• Excellent organizational skills, with attention to detail and accuracy.

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 $100,000 to $115,000 depending on skills, competency, and the market demand for your expertise.