Johnson & Johnson is on FGB’s Best Companies for Women of 2020.
FGB'ers gave this company a 4.3/5 in overall job satisfaction
FGB’ers working at Johnson & Johnson rated their manager’s support a 4.4/5
Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
Global exercise reimbursement.
Two weeks off (one of them fully paid) for volunteer work.
Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist in Springhouse, PA or Remote work options may be considered, on a case-by-case basis and if approved by the Company. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies. 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. 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 Immunology therapeutic area. Key Responsibilities: 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 Collaborate closely 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 Stay on top of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas. Qualifications Education: Minimum of a Bachelor’s Degree plus 6 years of relevant experience or a master level degree plus 4 years of relevant experience or a PharmD/PhD with 2 years of relevant experience. Experience and Skills: Required: Previous health regulated industry experience Understanding of the drug development process Understanding of the regulatory submission and approval process Knowledge of the regulatory environment, US guidelines and practices Candidate must be able to work optimally within a team environment and as an individual contributor. Project management, oral & written communication skills, organization and multi-tasking skills Preferred: Direct experience in regulatory affairs Regulatory, Clinical or R&D experience with products in early and late development stages Experience responding to FDA requests, leading FDA interactions, and lifecycle management of IND/NDA applications Immunology Drug Development experience Other: 10% domestic travel and potential international travel will be required for this position At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Primary Location United States-Pennsylvania-Spring House-Welsh & McKean Roads Other Locations North America-United States Organization Janssen Research & Development, LLC (6084) Job Function Regulatory Affairs Requisition ID 2206013233W
Child care benefits
Short term disability