Sr. RA professional- Global Regulatory Scientist

Job Sub Function:
Regulatory Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Leiden, Netherlands

Job Description:

Johnson & Johnson Innovative Medicine is recruiting for Sr. RA professional
- Global Regulatory Scientist, Regulatory Affairs to support the initiatives for the Interventional Oncology group (INTO). The position focuses on novel interventional oncology products, including combination products and platforms with limited regulatory precedent, designed to deliver therapies directly into the tumor. Preferred location: EU – Netherlands

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

Johnson & Johnson Innovative Medicine R&D is recruiting for Sr. RA professional - Global Regulatory Scientist, Regulatory Affairs (PG 26)

• Draft cover letters and support the preparation of various applications ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions
• For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions):
  Provide regulatory support throughout registration process
• Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate)
• Assist with timely NDA, MAA (other) document availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other)
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Assist in the preparation of meetings with Regulatory Agencies. Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• May include other activities as delegated by the RRL/GRL.
• Liaise with Local Operating Companies (LOCs), track dates of submissions/responses to queries in a timely manner.
• Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Partner with regulatory colleagues understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
• May assist in the development and improvement of regulatory processes.

• Bachelor’s Degree in a scientific or equivalent subject area with 6 years of relevant industry experience or Master’s degree with 4 years of relevant…