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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 https://www.jnj.com

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub** **Function:

Regulatory Science

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

Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs Biologics New Modalities. This position is a hybrid role and can be located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ.

The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of CMC regulatory professionals and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for innovative biologics, including Cell and Gene Therapy (CGT) products over their lifecycle.

Principal Responsibilities:

+ Collaborate closely with senior leadership to shape strategic direction in critical areas, fostering a high-performance organization with consistent application of practices, policies, systems and programs.

+ Lead planning, organization, and resource allocation within CMC Regulatory Affairs, focusing on new modalities, such as CGT. Partner with business support teams to drive the execution of key projects and workstreams.

+ Lead initiatives within CMC Regulatory Affairs (RA)/Global Regulatory Affairs (GRA) for the Biologics New Modalities group.

+ Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or multiple products.

+ Identify, prioritize and drive projects and workstreams. Ensure that appropriate objectives and metrics are established, monitored and met, including removing barriers.

+ Participate in and conduct due diligence/licensing evaluations as needed.

+ Train, coach and develop team members.

+ Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Senior Management.

+ Represent CMC RA on Cross Functional Governance Committees.

+ Serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise related to innovative biologics.

+ Create engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills.

+ Enable a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group.

Qualifications:

+ A minimum of a Bachelor’s degree is required, preferably in Cell and Molecular Biology, Pharmaceutical Sciences, Chemistry or Bioengineering. An advanced degree (Master’s, Ph.D., Pharm. D.) is preferred.

+ A minimum of 12 years of experience, inclusive of post graduate education, in the pharmaceutical, healthcare or related industry is required.

+ Solid understanding of biology, chemistry and/or bioengineering relevant to pharmaceutical industry is required.

+ Proven track record and/or strong understanding in developing and implementing successful CMC regulatory lifecycle strategies is required.

+ Expertise in product development and how it is applied to global regulatory strategies is required.

+ Experience leading health authority interactions is required.

+ Strong knowledge of global regulatory laws, regulations, guidance and submission routes pertaining to drugs from early development to commercial maturity is required.

+ Good understanding of competitors in the area and their current activities in early/late development within Biologics New Modalities space, including Cell and Gene Therapy, is required.

+ People management experience is preferred.

+ Experience in leading a diverse community of professionals in a global and matrix environment is required.

+ Must have excellent verbal and written communication skills.

+ Must be a seasoned leader, decision maker and constructive challenger.

+ Must demonstrate model behavior that understands what the priorities are and encourages others to drive for results.

+ The ability to communicate cross-functionally and cross-company, present and defend CMC management-approved regulatory strategy to project teams and recognize and account for global regulatory impact is required.

The anticipated base pay range for this position is $160,000 to $276,000.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

+ Vacation - up to 120 hours per calendar year

+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

+ Holiday pay, including Floating Holidays - up to 13 days per calendar year

+ Work, Personal and Family Time - up to 40 hours per calendar year

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

This job posting is anticipated to close on August 14, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

\#LI-Hybrid

The anticipated base pay range for this position is :

The anticipated base pay range for this position is $160,000 to $276,000.

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: • Vacation - up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year • Holiday pay, including Floating Holidays - up to 13 days per calendar year • Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.