Johnson & Johnson Innovative Medicine
Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)
Lead Regulatory Scientist position in Global Regulatory Affairs (Oncology) at Janssen/Johnson & Johnson. Preference for location in New Jersey or Pennsylvania. Overview
Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist to support regulatory activities for compounds in development and/or marketed products in the Oncology portfolio. The role supports the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) and collaborates with Local Operating Companies to ensure regulatory strategy alignment and timely submissions. Key Responsibilities
Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader for regulatory activities for products in the assigned portfolio, ensuring 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 and project-specific issues. Develop understanding of the regional regulatory environment, competitor intelligence, and therapeutic area. Act as back-up contact with Regulatory Agencies as needed. Draft cover letters for Regulatory Agency communication and assist in preparing meetings with Regulatory Agencies. Collaborate with Local Operating Companies (LOCs) to ensure timely responses to queries and consistency with the regulatory strategy. Assist in the development and improvement of processes related to regulatory submissions. Review clinical trial plans and protocols for regulatory alignment; provide regulatory input throughout the registration process and lifecycle management. Advise on required documents and submission strategies in collaboration with LOCs. Prepare submission documents, ensure components are in place on time, and support submission planning and acceptance. Draft and review document content as appropriate to regulatory knowledge and expertise. Lead cross-functional team meetings as appropriate; stay informed on submission details and collaborate with Submission Management. Provide regulatory input for inspections, audits, litigation support, and product complaints; participate as Regulatory representative on multi-discipline teams. Maintain knowledge of current and pending approvals in Oncology and applicable laws, guidances, and requirements. Qualifications
Education Bachelor’s Degree plus 6 years of industry experience (required) Master’s degree plus 4 years of experience (preferred) PharmD/PhD with 2 years of relevant experience (preferred) Experience and Skills Previous health-regulated industry experience Understanding of the drug development process Solid understanding of regulatory submission and approval process Knowledge of US guidelines and practices in the regulatory environment Ability to work in a diverse team and as an individual contributor Project management, oral and written communication, organization and multitasking skills Teamwork, including effective communication and conflict resolution Strong organizational and time-management skills Critical thinking with contingency planning aligned to corporate objectives Problem solving and goal setting for improved efficiencies Preferred Direct experience in regulatory affairs Oncology drug development experience Regulatory, Clinical or R&D experience with products in early and late development stages Experience responding to FDA requests, FDA interactions, lifecycle management of IND/NDA/BLA Other This position may require less than 10% travel. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. This position involves an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact the appropriate resource.
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Lead Regulatory Scientist position in Global Regulatory Affairs (Oncology) at Janssen/Johnson & Johnson. Preference for location in New Jersey or Pennsylvania. Overview
Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist to support regulatory activities for compounds in development and/or marketed products in the Oncology portfolio. The role supports the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) and collaborates with Local Operating Companies to ensure regulatory strategy alignment and timely submissions. Key Responsibilities
Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or Global Regulatory Leader for regulatory activities for products in the assigned portfolio, ensuring 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 and project-specific issues. Develop understanding of the regional regulatory environment, competitor intelligence, and therapeutic area. Act as back-up contact with Regulatory Agencies as needed. Draft cover letters for Regulatory Agency communication and assist in preparing meetings with Regulatory Agencies. Collaborate with Local Operating Companies (LOCs) to ensure timely responses to queries and consistency with the regulatory strategy. Assist in the development and improvement of processes related to regulatory submissions. Review clinical trial plans and protocols for regulatory alignment; provide regulatory input throughout the registration process and lifecycle management. Advise on required documents and submission strategies in collaboration with LOCs. Prepare submission documents, ensure components are in place on time, and support submission planning and acceptance. Draft and review document content as appropriate to regulatory knowledge and expertise. Lead cross-functional team meetings as appropriate; stay informed on submission details and collaborate with Submission Management. Provide regulatory input for inspections, audits, litigation support, and product complaints; participate as Regulatory representative on multi-discipline teams. Maintain knowledge of current and pending approvals in Oncology and applicable laws, guidances, and requirements. Qualifications
Education Bachelor’s Degree plus 6 years of industry experience (required) Master’s degree plus 4 years of experience (preferred) PharmD/PhD with 2 years of relevant experience (preferred) Experience and Skills Previous health-regulated industry experience Understanding of the drug development process Solid understanding of regulatory submission and approval process Knowledge of US guidelines and practices in the regulatory environment Ability to work in a diverse team and as an individual contributor Project management, oral and written communication, organization and multitasking skills Teamwork, including effective communication and conflict resolution Strong organizational and time-management skills Critical thinking with contingency planning aligned to corporate objectives Problem solving and goal setting for improved efficiencies Preferred Direct experience in regulatory affairs Oncology drug development experience Regulatory, Clinical or R&D experience with products in early and late development stages Experience responding to FDA requests, FDA interactions, lifecycle management of IND/NDA/BLA Other This position may require less than 10% travel. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. This position involves an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact the appropriate resource.
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