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Lead Regulatory Scientist

Company: Disability Solutions
Location: Spring House
Posted on: February 10, 2024

Job Description:

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead Regulatory Scientist. This position can be located in Spring House, PA; Malvern, PA, Raritan, NJ; or Titusville, NJ. Remote locations within the United States may be considered on a case-by-case basis and if approved by the company. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare. GRA is a key strategic partner supporting global R&D initiatives. As a Lead Regulatory Scientist, you will support drug development programs as well as marketed products across multiple therapeutic areas. You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals. Through hands-on, real world experiences, you will work on projects that improve your leadership, problem-solving, and creative thinking skills. In addition, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment. Principal Responsibilities:

  • Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned.
  • Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area.
  • Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed.
  • Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
  • Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate.
  • Advise team in required documents and submission strategies.
  • Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements.
  • Support the development and improvement of processes related to regulatory submissions.
  • Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints.
  • Stay on top of current and pending approvals in assigned therapeutic areas and be knowledgeable of laws, guidances and requirements related to those areas.
  • May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent Johnson & Johnson/Janssen externally with some degree of supervision.

Keywords: Disability Solutions, Philadelphia , Lead Regulatory Scientist, Other , Spring House, Pennsylvania

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