Regulatory CMC Director

This late-stage biotechnology company is developing first-in class T Cell based cancer immunotherapies.  They are seeking a Regulatory CMC Director who can contribute to global Regulatory CMC strategy and execution for their commercial biologic product. You will prepare and submit global post-approval CMC filings to global health authorities and work closely with cross-functional teams.  This company offers innovative science, a patient-focused company culture, and the ability to work remotely.  With their first rolling BLA in progress, now is an exciting time to join this innovative organization!   


  • Participate in the development of global CMC regulatory strategy and execution of post-approval filings for an approved biologic drug product.
  • Manage and implement planning, preparation and submission of high-quality CMC filings in 13 countries.
  • Actively seek out knowledge of overall corporate planning and other factors that affect the CMC regulatory positions taken within the company and incorporate this knowledge into submission planning.
  • Exercise judgment on complex issues by interpreting product data against Health Authority requirements.
  • Deliver high-quality CMC submissions by taking ownership of assigned submissions and then working with functions to align on submission content.
  • Ensure CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual Health Authorities.
  • Build and manage relationships through active partnering with key internal and external stakeholders.
  • Proactively identify risks to submission timelines and content.
  • Stay current with regulatory requirements and initiate process improvements as appropriate.



  • Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
  • Ten or more years of experience in Regulatory CMC for pharmaceutical drugs and biologics.
  • Post-approval Regulatory CMC experience with proteins and monoclonal antibodies highly preferred.
  • Demonstrated track record of successful CMC submissions to FDA and other health authorities.
  • Must have strong global/international Regulatory CMC filing experience (EMA, Health Canada, Asia Pacific, etc).
  • Experience in post-approval dossier life cycle management and direct interactions supporting health authority GMP inspections desirable.
  • Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
  • Strong organizational and planning skills along with outstanding written and verbal communication skills.
  • Proven ability to communicate effectively and efficiently cross functionally and with regulatory agencies.
  • Ability to build positive relationships with co-workers of various backgrounds and expertise.
  • Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
  • Must be comfortable with ambiguity within an evolving company.


The budgeted salary range for this position is $210,000 to $240,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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