Director, CMC Regulatory Affairs

Johnson & Johnson•Titusville, PA

19h•Hybrid

About The Position

As Director CMC Regulatory Affairs Synthetics New Modalities, you will lead a team of experts and develop, implement and maintain the global CMC strategy for our most innovative synthetic product portfolio. In this role, you will combine in-depth technical expertise with strategic insight to navigate complex regulatory landscapes and drive innovation within Johnson & Johnson.

Requirements

BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering.
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.

Nice To Haves

MS, Ph.D., or Pharm.D. preferred.

Responsibilities

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.
Represents CMC RA on cross-functional teams
Ensure the highest regulatory standards while promoting a culture of innovation.

Benefits

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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year