Johnson & Johnson Careers
Regulatory Scientist, Global Regulatory Affairs.
Raritan, New Jersey; Spring House, Pennsylvania
Requisition ID: 3324190905
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Regulatory Scientist, Global Regulatory Affairs. The position will be based Raritan, NJ or Springhouse PA.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
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, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. 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
The Regulatory Scientist, provides 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.
Key responsibilities include the following and may vary based on job level and regional responsibility:
• 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 in timely manner, and that content is consistent with the regulatory strategy;
• Assist in development and improvement of processes related to regulatory submissions.
As the Regulatory Scientist,
• You will 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.
• One of the following combinations of education and experience is required: (A) a minimum of a Bachelor’s Degree plus 4 years of relevant experience OR (B) a master level degree plus 2 years of relevant experience OR (C) a PharmD/PhD with 1 year relevant experience.
• An advanced degree (MS, Pharm D, PhD) is highly preferred,
• Previous health regulated industry experience is required.
• Oncology Drug Development experience is preferred.
• Understanding of the drug development process is required.
• 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 preferred.
• Candidate must be able to work successfully within a team environment and as an individual contributor.
• Knowledge of data sciences, machine learning, and natural language processing are preferred.
• Project management/lead experience is preferred
oral & written communication skills, organization and multi-tasking skills are required.
• The preferred location for this position is Raritan, NJ however Springhouse PA is acceptable
• This position may require up to 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.
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United States-New Jersey-Raritan-
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC (6084)