Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist - Oncology. The preferred locations are Raritan, New Jersey or Springhouse, PA. Remote flexibility may be considered.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, immunology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market - from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Lead Regulatory Scientist provides support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.
The Lead Regulatory Scientist will:
Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy.
Participate in global regulatory team meetings as appropriate
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
Act as back-up for contact with Regulatory Agencies as needed
Draft cover letters for Regulatory Agency communication
Assist in the preparation of meetings with Regulatory Agencies
Liaise with LOCs, and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
Assist in the development and improvement of processes related to regulatory submissions.
Review clinical trial plans and protocols and ensure alignment with regulatory requirements
Provide regulatory support throughout registration process and life-cycle management
Advise team in required documents and submission strategies (in collaboration with LOCs as appropriate)
Assist with timely availability of submission documents and ensure that all document components are in place on time
Draft and review some document content (depending on level of regulatory knowledge/expertise)
Prepare, hold and lead cross functional team meetings as appropriate
Understand submission details and liaise with Submission Management
Review and approve submission plans
Review of submission documents to ensure compliance with regulatory requirements
Assist with submission and acceptance of the submission package
Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
Serve as the Regulatory representative on specific multi-discipline teams
Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas.
Qualifications
Qualifications
One of the following combinations of education and experience is required: (A) a minimum of a Bachelor's Degree plus 6 years of relevant experience OR (B) a master level degree plus 4 years of relevant experience OR (C) a PharmD/PhD with 2 year relevant experience
Previous health regulated industry experience is required
Understanding of the drug development process is required
Oncology Drug Development experience is preferred
Understanding of the regulatory submission and approval process is required
Knowledge of the regulatory environment, US guidelines and practices is required
Direct experience in regulatory affairs is desirable
Regulatory, Clinical or R&D experience with products in early and late development stages is preferred
Experience responding to FDA requests, managing FDA interactions, and lifecycle management of IND/NDA/BLA applications is preferred
Candidate must be able to work successfully within a team environment and as an individual contributor
Project management, oral & written communication skills, organization and multi-tasking skills are required
This position may require less than 10% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
United States-Virginia-Richmond, United States-Pennsylvania-Philadelphia, United States-Massachusetts-Boston, United States-Florida-Miami, United States-Florida-Tampa, United States-Illinois-Chicago, United States-New Jersey-Titusville, United States-New York-New York, United States-Ohio-Cincinnati, United States-Pennsylvania-Spring House, North America-United States-Indiana-Indianapolis, North America-United States-Michigan-Detroit, North America-United States-Maryland-Baltimore, North America-United States-Georgia-Atlanta, United States-Pennsylvania-Horsham, United States-Delaware-Wilmington, United States-Florida-Jacksonville
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2105915244W