Director, CMC Regulatory Affairs
$164k/y-$282.9k/y
Johnson & Johnson Innovative Medicine3 days ago
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HybridFull-timeDirector
Summary
Johnson & Johnson Innovative Medicine is seeking a Director, CMC Regulatory Affairs to lead a team in developing and implementing the global CMC strategy for their innovative synthetic product portfolio. This hybrid position can be located in various locations including Beerse, Belgium, Warsaw, Poland, and Spring House, PA.
About the Role
As the Director of CMC Regulatory Affairs, you will coach and inspire a high-performing team, translate complex objectives into measurable results, collaborate with senior leadership, and ensure compliance with the highest regulatory standards while fostering a culture of innovation.
About You
Required:
- BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering.
- 12+ years of experience within the pharmaceutical/healthcare industry, focusing 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 lead cross-functional teams.
Preferred:
- MS, Ph.D., or Pharm.D. in a relevant field.
- Strategic mindset with the ability to identify priorities and drive results.
Benefits
- Competitive salary range of $164k–$282.9k.
- 120 hours of vacation per calendar year.
- 40 hours of sick time per calendar year.
- 13 days of holiday pay, including floating holidays.
- Parental leave of 480 hours within one year of the birth/adoption/foster care of a child.
- Bereavement leave of 240 hours for an immediate family member.
- Caregiver leave of 80 hours in a 52-week rolling period.
- Volunteer leave of 32 hours per calendar year.
Johnson & Johnson Innovative Medicine
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Spring House, PA