Manager, Regulatory CMC

Jersey City, NJ

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  

As the Manager, Regulatory CMC you will be a key member of our Regulatory CMC team, responsible for preparing the strategy and documents for regulatory submissions. This individual will shepherd CMC workflows, through Veeva and other project management tools, for early to late-stage projects. Your expertise in pharmaceutical development and regulatory CMC will be essential in driving our regulatory submissions and ensuring quality, safety, and efficacy.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York City (NYC) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

You are a dedicated professional with a passion for ensuring the successful development of pharmaceutical products. Your collaborative nature is the cornerstone of your work philosophy, as you thrive on building strong relationships with cross-functional teams. Your keen attention to detail is second nature, as you meticulously oversee the intricacies of meeting regulatory objectives. The prospect of guiding innovations through the complex web of regulations energizes you. With every project, your goal is to merge the precision of regulatory requirements with the excitement of pioneering research and development, ensuring that the medicines of tomorrow are not only groundbreaking but also manufactured with the highest quality standards.

What You’ll Do

  • CMC Strategy: Develop and execute comprehensive CMC strategies for both early and late-stage projects, ensuring alignment with regulatory requirements and company goals.
  • Regulatory Submissions: Collaborate with cross-functional teams to prepare and compile CMC documentation for regulatory submissions, including Investigational New Drug (IND), Investigational Medicinal Product Dossier (IMPD), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions.
  • Veeva System Management: Utilize your expertise in Veeva or equivalent systems to manage and maintain CMC-related documentation, ensuring accurate and up-to-date records throughout the drug development lifecycle.
  • Technical Oversight: Provide technical leadership and guidance to internal and external stakeholders regarding CMC processes, manufacturing, analytical development, and quality control.
  • Risk Management: Identify potential risks and challenges related to CMC activities, proactively develop mitigation strategies, and contribute to decision-making processes.
  • Cross-Functional Collaboration: Collaborate closely with R&D, Manufacturing, Clinical Supply, Quality Assurance, Regulatory Affairs Clinical Strategy, and other teams to ensure seamless integration of CMC activities into overall project timelines and objectives.
  • Quality Standards: Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant industry regulations, standards, and guidelines to maintain the highest quality of pharmaceutical products.

Qualifications

  • Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
  • Prior experience in a Regulatory CMC role or equivalent experience in pharmaceutical development roles preferred.
  • Proficiency in using Veeva or equivalent electronic document management systems.
  • In-depth understanding of regulatory requirements related to CMC for pharmaceutical products (FDA, EMA, ICH, etc.).
  • Strong project management skills and the ability to effectively manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams.
  • Leadership experience, including managing teams and fostering a collaborative work environment.
  • Problem-solving mindset, with the ability to analyze complex issues and develop strategic solutions.
  • Preferred experience with global regulatory submissions, including participation in IND, IMPD, NDA, MAA and/or post-approval variation submissions.

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 $135,000 to $147,250 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.

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