Lead Regulatory Scientist
Company: Disability Solutions
Location: Spring House
Posted on: February 10, 2024
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
- 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
- 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
- Review clinical trial plans, protocols and submission plans
ensuring alignment with regulatory requirements.
- Support the development and improvement of processes related to
- 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
Keywords: Disability Solutions, Philadelphia , Lead Regulatory Scientist, Other , Spring House, Pennsylvania
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