Principal Scientist, CMC Regulatory Dossier Development

Company: Disability Solutions
Location: Spring House
Posted on: February 15, 2025

Job Description:

Johnson & Johnson is recruiting for a Principal Scientist, CMC Regulatory Dossier Development which can be located in Spring House, PA; Horsham, PA; Malvern, PA; Raritan, NJ; Beerse, Belgium; Leiden, Netherlands; Cork, Ireland or Schaffhausen, Switzerland. Remote work options may be considered on a case-by-case basis and if approved by the Company.\rAt 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/.\rFor 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.\rWe 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.\rAt Johnson & Johnson, we all belong.\rThe Principal Scientist, Dossier Development, with some managerial guidance, develops the technical eCTD sections for Regulatory CMC dossier applications, coordinating and providing the technical oversight for the generation of the CMC dossier for marketing and clinical trial submissions. Coordinates the timelines, virtual document, and Quality module generation while assuming ownership for business results and solutions. Represents the department on multi-functional project development teams to support regulatory filings and authors/drives sections of the CMC dossier ensuring compliance with regulatory requirements.\rThe Principal Scientist supports technical functions in developing responses to health authority inquiries for clinical trials and marketing applications, ensuring the completeness, accuracy and compliance of data provided for all regulatory submissions. Ensures timely completion of Quality submissions.\rKey Responsibilities:

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• Supports and implements dossier strategy/product development plans with autonomy.
• Manages project budgets and may lead dossier authoring activities for late-stage regulatory filings with some managerial support.
• Identifies and drives business improvements within the functional organization and collaborates with other departments as needed.
• Work with CMC/Tech team members, Regulatory, Janssen Supply Chain, external service providers and internal Discovery, Product Development and Supply customers such as Global Clinical Operations and Therapeutic Areas.
• Collaborate with internal and some external partners, influencing alignment on new ideas and approaches.
• Combine technical expertise with managerial skills and may manage consultants.
• Handle a limited number of standard projects or, with assistance, complex projects with accelerated priority.
• Challenges the status quo and identifies innovative process improvements.
• Make day-to-day operational decisions and allocates resources, while working independently and checking in weekly with a supervisor.
• Manages functional or project teams of up to 10 members.\r\r

Keywords: Disability Solutions, Philadelphia , Principal Scientist, CMC Regulatory Dossier Development, Other , Spring House, Pennsylvania