Manager Global Regulatory Scientist, Regulatory Affairs in High Wycombe

Overview

Johnson & Johnson is a global healthcare company dedicated to innovative medicine and medical devices.

This role is for a Manager Global Regulatory Scientist within Regulatory Affairs.

The position is hybrid and available in Beerse, Belgium; Leiden, Netherlands; High Wycombe/Maidenhead, UK; or Raritan, NJ and Spring House, PA (USA).

Responsibilities

• Draft cover letters and support the preparation of regulatory submissions and related documents for IND, CTA, MAA/NDA and e CTD submissions.
• For CTA/INDs, ensure protocols align with regulatory requirements and advise on required documents and submission strategies.
• Provide regulatory support throughout the registration process for Marketing Authorizations (NDA, MAA, etc.).
• Advise on required documents and submission strategies in NDA/MAA filings (in collaboration with local operating centers as appropriate).
• Assist with timely NDA/MAA availability and ensure document components are in place on time; identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, and others); prepare country-specific submission packages for LOCs.
• Assist in the preparation of meetings with Regulatory Agencies and coordinate content for responses to queries from Health Authorities to ensure high quality, timely responses.
• Act as backup contact on multi-discipline teams or with regulatory agencies as needed; may organize and lead meetings.
• Provide regulatory input for inspections, audits, litigation support, and product complaints.
• Support GRL/GRT by driving high-level project management for global submissions and Health Authority interactions.
• Participate in global regulatory team meetings and assist in strategy development by researching regulatory and medical information for submissions.
• Advise the Regulatory team on applicable regulatory requirements and project-specific issues; partner with regulatory colleagues to understand the competitive landscape and labeling differences.
• Assist in the development and improvement of regulatory processes.

Qualifications

• Bachelor's degree in a scientific or equivalent discipline; advanced scientific degree preferred.
• Minimum of 4 years in health-regulated industry experience (or Master's with 5 years; Ph D/Pharm D with 4 years).
• At least 4 years of relevant regulatory affairs experience in pharmaceutical/biotech industry.
• Knowledge of multiple global health authorities' regulations and processes; solid understanding of FDA and ICH requirements related to clinical research, product development, life-cycle submissions, and labeling.
• Therapeutic area experience in oncology is beneficial. Experience with combination products (drug and device) is an asset.
• Strong curiosity and ability to learn new areas with limited regulatory precedence; ability to work across different product types (pharma, devices, combo products).
• Experience preparing responses to Health Authorities and managing Health Authority interactions and lifecycle management of trials and marketing authorizations (IND/CTA, NDA/MAA, BLA, etc.).
• Experience in strategic planning, technical data summaries, and cross-functional management.
• Leadership capabilities: strong organizational and time management, collaboration, conflict resolution, and ability to work in a matrixed environment.
• Strong critical thinking, problem-solving, and strategic planning skills.
• Willingness to travel (approximately 10% domestic; international travel may be required).