Mgr Global Regulatory Scientist, Reg Aff

Job Function

Regulatory Affairs Group

Regulatory Affairs

Professional

Raritan, New Jersey, United States of America;
Spring House, Pennsylvania, United States of America

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured; where treatments are smarter and less invasive; and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

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.

• Draft cover letters and support the preparation of various applications (e.g., 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 the 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) 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 LOCs, track dates of submissions/responses to queries in a timely manner.
• Act as backup contact/representative on specific multidisciplinary 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.
• Support 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 to 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.

• A Bachelor's degree in a scientific or equivalent discipline; an advanced scientific degree is preferred, with at least 6 years of health‑regulated industry experience, or a Master's degree with a minimum of 5 years of health‑regulated industry experience, or a PhD/PharmD with a minimum of 4 years of health‑regulated experience.
• At least 4 years of relevant regulatory affairs experience in the pharmaceutical/biotech industry is required.
• Opportunity to flex across different product types (pharma, devices, combo products).
• Knowledge of multiple global health authorities’ regulations and processes would be ideal.
• Solid understanding of FDA and ICH regulatory requirements and guidelines specific to the areas of clinical research, product development, life‑cycle…