Principal Scientist, CMC Regulatory Affairs

Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; Horsham, PA; Malvern, PA or Spring House, PA.

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/.

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 Principal Scientist, CMC Regulatory Affairs provides support for the registration activities for a diverse portfolio of biologic drug products. This includes country specific requirements, supporting documentation for renewals, annual reports, variations, and affiliate and health authority questions for both new products and post approval changes.

Key Responsibilities:

• Track country approvals and ensure databases accurately reflect registration status.
• Provide regular contact with other J&J affiliates around the world both in the Regulatory Affairs department and manufacturing sites.
• Interact with external partners including contract manufacturing sites.
• Under the direction of management, support pre- and post-approval drug substances and/or drug products for biologics by preparing regulatory dossiers for submission to health Authorities.
• Contribute to the development of global CMC regulatory strategies and content plans, ensures that development strategy meets global regulatory requirements over product lifecycles, and further ensures that CMC regulatory strategy is in alignment with global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile.
• Actively participate on Global Regulatory Teams to develop global marketing approval submission plans and provide accurate regulatory assessments of CMC changes to teams and execution of regulatory planning and implementation.