Global Regulatory Scientist Lead - Submissions & Strategy

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybride; EUR 90 000 - 150 000; Plein temps

Résumé du poste

Johnson & Johnson, a global health leader, seeks a Regulatory Affairs professional to support Global Regulatory Science with a hybrid work arrangement across Beerse, Leiden, High Wycombe, Raritan, and Spring House. The role focuses on regulatory submissions, strategy, and cross-functional collaboration.

The successful candidate will guide CTA/INDs, NDA/MAA processes, and country-specific submissions, coordinating with LOCs and health authorities while leading meetings and driving process

Qualifications

• Bachelor's degree in a scientific or equivalent discipline; advanced degree preferred.
• At least 6 years of health-regulated industry experience; or a Master’s with at least 5 years; or a PhD/PharmD with at least 4 years of health-regulated experience.
• Minimum 4 years of regulatory affairs experience in pharmaceutical/biotech industry.
• Knowledge of FDA and ICH regulatory requirements for clinical research, product development, lifecycle submissions, and labeling.
• Therapeutic area experience in oncology is beneficial; experience with combination products is an asset.
• Strong project planning, cross-functional management, and strategic thinking; ability to work in a matrixed environment.
• Leadership capabilities with strong organizational, communication, and conflict resolution skills.
• Willingness to travel domestically and internationally as needed (approximately 10%).
• Open to working across multiple product types (pharma, devices, combo products).

Responsabilités

• Draft cover letters and support preparation of regulatory submissions (IND, CTA, MAA/NDA, eCTD).
• Provide regulatory guidance for CTA/INDs, align protocols with regulatory requirements, and advise on required documents and submission strategies.
• Support Marketing Authorization Applications (NDA, MAA, and other major HA submissions) and advise on documents and strategies in collaboration with LOCs.
• Assist with ensuring timely NDA/MAA availability, verify document components are in place, and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications; prepare country-specific submission packages for LOCs.
• Assist in preparation of regulatory agency meetings and coordinate content for responses to queries from health authorities to ensure high quality, timely answers.
• Act as back-up contact on multi-discipline teams or with regulatory agencies as needed; may lead meetings and organize activities.
• Provide regulatory input for inspections, audits, litigation support, and product complaints; support GRL/GRT with project management planning of global submissions and major milestones.
• 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-related issues; partner with regulatory colleagues to understand competitive landscape and labeling considerations.
• Contribute to development and improvement of regulatory processes as applicable.

Connaissances

Regulatory affairs

Project planning

Cross-functional teamwork

Strategic thinking

Leadership

Communication

Travel willingness

Formation

Bachelor's degree in science

Master’s degree

PhD/PharmD

Description du poste

Johnson & Johnson, a global health leader, seeks a Regulatory Affairs professional to support Global Regulatory Science with a hybrid work arrangement across Beerse, Leiden, High Wycombe, Raritan, and Spring House. The role focuses on regulatory submissions, strategy, and cross-functional collaboration.

The successful candidate will guide CTA/INDs, NDA/MAA processes, and country-specific submissions, coordinating with LOCs and health authorities while leading meetings and driving process