Johnson & Johnson Innovative Medicine
Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)
Our expertise in Innovative Medicine informs and inspires our science-based advancements. Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist in Global Regulatory Affairs (Oncology). The preferred location is New Jersey or Pennsylvania. Responsibilities include supporting the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities in the Oncology portfolio, developing and executing regulatory strategies, coordinating with LOCs, and ensuring timely regulatory submissions and lifecycle management. Key Responsibilities: Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or GRL for regulatory activities; ensure content and intent of filings align with global regulatory strategy Participate in global regulatory team meetings; advise on regulatory requirements and project-specific issues Develop understanding of regional regulatory environments, competitor intelligence, and therapeutic area Act as back-up contact with Regulatory Agencies as needed Draft cover letters for Regulatory Agency communications and assist in preparation of agency meetings Collaborate with Local Operating Companies (LOCs) to ensure timely responses to queries and alignment with regulatory strategy Develop and improve processes related to regulatory submissions Review clinical trial plans and protocols for regulatory alignment; provide regulatory support throughout registration and life-cycle management Advise on required documents and submission strategies; ensure submission documents are ready on time Draft/review content as appropriate; prepare and lead cross-functional team meetings Understand submission details and collaborate with Submission Management; review and approve submission plans Ensure country-specific submission packages are available to LOCs per plans; provide input for inspections, audits, and product complaints Represent regulatory on multi-discipline teams and stay current on approvals and applicable laws and guidelines 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 relevant experience (preferred) Experience and Skills Health-regulated industry experience; understanding of the drug development process Solid understanding of regulatory submission and approval processes; knowledge of US guidelines Ability to work in a diverse team and as an individual contributor Project management, oral and written communication, organization, and multi-tasking skills Teamwork and conflict-resolution skills; strong organizational and time-management abilities Critical thinking, contingency planning aligned with corporate objectives Problem solving and goal setting for efficiency Preferred Direct experience in regulatory affairs Oncology drug development experience Regulatory/Clinical/R&D experience with products in early and late development stages Experience responding to FDA requests and lifecycle management of IND/NDA/BLA Other This position may require less than 10% travel. EEO Statement: Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by 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. The anticipated base pay range for this position is $105,000-$169,050. This information is provided for pay transparency and may be adjusted based on location, experience, and company policy.
#J-18808-Ljbffr
Our expertise in Innovative Medicine informs and inspires our science-based advancements. Janssen Research & Development, LLC is recruiting for a Lead Regulatory Scientist in Global Regulatory Affairs (Oncology). The preferred location is New Jersey or Pennsylvania. Responsibilities include supporting the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities in the Oncology portfolio, developing and executing regulatory strategies, coordinating with LOCs, and ensuring timely regulatory submissions and lifecycle management. Key Responsibilities: Provide support to the Regional Regulatory Liaison, Regional Therapeutic Area Leader and/or GRL for regulatory activities; ensure content and intent of filings align with global regulatory strategy Participate in global regulatory team meetings; advise on regulatory requirements and project-specific issues Develop understanding of regional regulatory environments, competitor intelligence, and therapeutic area Act as back-up contact with Regulatory Agencies as needed Draft cover letters for Regulatory Agency communications and assist in preparation of agency meetings Collaborate with Local Operating Companies (LOCs) to ensure timely responses to queries and alignment with regulatory strategy Develop and improve processes related to regulatory submissions Review clinical trial plans and protocols for regulatory alignment; provide regulatory support throughout registration and life-cycle management Advise on required documents and submission strategies; ensure submission documents are ready on time Draft/review content as appropriate; prepare and lead cross-functional team meetings Understand submission details and collaborate with Submission Management; review and approve submission plans Ensure country-specific submission packages are available to LOCs per plans; provide input for inspections, audits, and product complaints Represent regulatory on multi-discipline teams and stay current on approvals and applicable laws and guidelines 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 relevant experience (preferred) Experience and Skills Health-regulated industry experience; understanding of the drug development process Solid understanding of regulatory submission and approval processes; knowledge of US guidelines Ability to work in a diverse team and as an individual contributor Project management, oral and written communication, organization, and multi-tasking skills Teamwork and conflict-resolution skills; strong organizational and time-management abilities Critical thinking, contingency planning aligned with corporate objectives Problem solving and goal setting for efficiency Preferred Direct experience in regulatory affairs Oncology drug development experience Regulatory/Clinical/R&D experience with products in early and late development stages Experience responding to FDA requests and lifecycle management of IND/NDA/BLA Other This position may require less than 10% travel. EEO Statement: Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by 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. The anticipated base pay range for this position is $105,000-$169,050. This information is provided for pay transparency and may be adjusted based on location, experience, and company policy.
#J-18808-Ljbffr