Director, CMC Regulatory Affairs

Title: Director, CMC Regulatory Affairs

Locations

• Horsham, Pennsylvania, United States of America
• Raritan, New Jersey, United States of America
• Titusville, New Jersey, United States of America
• Spring House, Pennsylvania, United States of America

Hybrid Work

Full time

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

People Leader

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Director, CMC Regulatory Affairs. This hybrid work position will be located in Beerse, Belgium, Warsaw, Poland, Allschwil, Switzerland, or our East Coast USA location (Horsham, PA, Spring House, PA, Titusville, NJ and Raritan, NJ)

Director, CMC Regulatory Affairs, Synthetics New Modalities

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.

What you will do:

• Leadership: Coach and inspire a high-performing team of CMC professionals, fostering a culture of continuous improvement and scientific excellence.

• Execution: Translate complex objectives into measurable results and projects.

• Collaboration: Act as the bridge between CMC RA and senior leadership to ensure an agile and competitive organization. Represents CMC RA on cross-functional teams

• Compliance & Ethics: Ensure the highest regulatory standards while promoting a culture of innovation.

Qualifications & Skills

• Education: BS in Biological, Pharmaceutical, Chemical Sciences, or Engineering. MS, Ph.D., or Pharm.D. preferred.

• Experience: 12+ years of experience within the pharmaceutical/healthcare industry, with a focus on CMC Regulatory Affairs.

• Expertise: Deep knowledge of global regulatory laws, guidance, and submission routes (ICH, FDA, EMA).

• Technical Understanding: Strong background in chemistry, biology or engineering relevant to product development.

• Leadership & Communication: Proven ability to communicate effectively and to lead cross-functional teams.

• Strategic Mindset: Ability to identify priorities, drive results, and act as a model of leadership.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).

• Belgium and Poland - Requisition Number: R-060515
• Switzerland - Requisition Number: R-060740

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$164,000.00 - $282,900.00

Additional Description for Pay Transparency:

• 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
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits