Director, CMC Regulatory Affairs 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:

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 a Director, CMC Regulatory Affairs New Modalities to be in Spring House, PA; Horsham, PA; Titusville, NJ; or Raritan, NJ.

Purpose:
The Director, CMC Regulatory Affairs New Modalities will lead a team of CMC regulatory professional’s and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for products over their lifecycle.

You will be responsible for:
•    Work closely with the senior leadership team in developing and proposing direction in key areas to ensure a high performing organization and consistent application of practices, policies, systems and programs 
•    Planning, organizing, and directing resources and activities within CMC RA. Drive the execution of identified projects and workstreams 
•    Lead selected initiatives within CMC RA / GRA 
•    Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s) 
•    Identify, prioritize and drive projects and workstreams. Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers 
•    Participates in and conducts due diligence/licensing evaluations as needed 
•    Responsible for training, coaching and development of the team members 
•    Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Senior Management 
•    Represents CMC RA on Cross Functional Governance Committees 
•    Serves as a SPOC/SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise 
•    Creates engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills 
•    Enables a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group 
•    Support the senior leadership in driving implementation of strategic plans 

Qualifications / Requirements:
 

Education:
•    Minimum of a Bachelor’s degree required, preferred areas of study include biological, pharmaceutical, chemical or engineering sciences
•    MS, Ph.D., or Pharm. D. degree is preferred
 

Required:
•    Minimum of 10-12 years of experience inclusive of post graduate education and/or pharmaceutical or healthcare industry experience 
•    Successful experience in leading a diverse community of professionals in a global and matrix environment. Seasoned leader, decision maker and constructive challenger.
•    Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
•    Proven track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy
•    Strong attention to detail with high-level verbal and written communication skills 
•    Makes decisions based on facts and sound scientific