Director, CMC Regulatory Affairs Biologics New Modalities
$160k/y-$276k/y
3 days ago
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HybridFull-timeSenior
Summary
Johnson & Johnson Innovative Medicine is seeking a Director, CMC Regulatory Affairs Biologics New Modalities to join their team in Horsham, PA. The role involves leading a team of CMC regulatory professionals and developing global CMC regulatory strategies for innovative biologics, including Cell and Gene Therapy products.
About the Role
As the Director, CMC Regulatory Affairs Biologics New Modalities, you will collaborate with senior leadership to shape strategic direction, lead planning and resource allocation, supervise CMC RA teams, and drive a culture of continuous improvement. You will also represent CMC RA on governance committees and serve as a subject matter expert on CMC regulatory expertise related to innovative biologics.
About You
Required:
- Bachelor's degree in Cell and Molecular Biology, Pharmaceutical Sciences, Chemistry, or Bioengineering.
- A minimum of 12 years of experience in the pharmaceutical or healthcare industry.
- Solid understanding of biology, chemistry, and/or bioengineering relevant to the pharmaceutical industry.
- Proven track record in developing and implementing successful CMC regulatory lifecycle strategies.
- Experience leading health authority interactions.
- Strong knowledge of global regulatory laws and submission routes.
Preferred:
- Advanced degree (Master's, Ph.D., Pharm. D.) in a relevant field.
- People management experience.
- Experience in leading a diverse community of professionals in a global environment.
- Excellent verbal and written communication skills.
Benefits
- Competitive base salary ranging from $160k to $276k.
- Annual performance bonus based on individual and company performance.
- Medical, dental, vision, life insurance, and disability coverage.
- 401(k) retirement plan with company match.
- Generous vacation and sick leave policies.
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
Horsham, PA