Director, CMC Regulatory Affairs Biologics New Modalities

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.