Regulatory Operations Senior Analyst

Johnson & Johnson is currently seeking a Regulatory Operations Senior Analyst to join our Specialty Compliance team located in Titusville, NJ or Horsham, PA.

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.

Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.

Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The Regulatory Operations Senior Analyst will report directly to the Manager, Specialty Compliance Regulatory Operations and will serve as a member of the Regulatory Operations team to deliver on the coordination of tasks, resources, and priorities impacting Regulatory Operations function, including aligning support to business needs (e.g.

submissions related to high-volume launches, safety updates, etc.).

Key responsibilities will include:

• Partner with business to ensure that emerging advertising and promotion technologies and mediums are consistent with applicable laws, regulations, guidelines and company policies related to the submission of advertising and promotion materials (e.g.

maintenance of high-quality and compliant submission to FDA of all promotional materials)

• Cultivate partnerships to ensure that submissions are timely, accurate, and consistent with FDA requirements, ensure proper record keeping and retention of submission in the system, partner with the Law Department and external counsel to respond to litigation document requests and update and train business on new FDA guidances, advising on process solutions (policies, systems, etc.) to support changing business models.

• Serve as an engaged member of the NA Program Management team with responsibilities for providing updates and driving consistency, engaging in strategy development, and providing oversight of projects and initiatives to advance the promotional compliance framework, including partnering to embed FDA requiremen...