Coach and inspire a high-performing team of CMC professionals, fostering a culture of continuous improvement and scientific excellence.
Translate complex objectives into measurable results and projects.
Act as the bridge between CMC RA and senior leadership to ensure an agile and competitive organization.
Ensure the highest regulatory standards while promoting a culture of innovation.

BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering.
MS, Ph.D., or Pharm.D. preferred.
12+ years of experience within the pharmaceutical/healthcare industry, with a focus on CMC Regulatory Affairs.
Deep knowledge of global regulatory laws, guidance, and submission routes (ICH, FDA, EMA).
Strong background in chemistry, biology or engineering relevant to product development.
Proven ability to communicate effectively and to lead cross-functional teams.
Ability to identify priorities, drive results, and act as a model of leadership.

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Director, CMC Regulatory Affairs

Key skills