Global Regulatory Submissions Lead

Jobtailor; Beerse; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Jobtailor is seeking an experienced Regulatory Affairs professional in Belgium to lead submissions (NDA/MAA/IND) and ensure alignment with FDA/ICH guidelines. You will coordinate cross-functional teams, manage lifecycle submissions, and support HA interactions throughout the regulatory process.

The role requires a strong track record in global submissions, strategic planning, and leadership within a matrixed organization. Advanced degree and oncology experience are beneficial assets.

Qualifications

• Bachelor’s degree in scientific discipline; advanced degree preferred.
• 6+ years in health-regulated industry, or Master’s with 5+ years, or PhD/PharmD with 4+ years of health-regulated experience.
• At least 4 years of regulatory affairs experience in pharmaceutical/biotech industry.

Responsabilités

• Draft cover letters and support regulatory submissions (IND, CTAs, NDA/MAA, eCTD).
• Ensure protocols align with regulatory requirements and advise on documents and submission strategies.
• Provide regulatory support throughout registration processes.
• Advise on documents and submission strategies for NDA/MAA as assigned.
• Assist with timely NDA/MAA availability and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
• Ensure country-specific submission packages are available to LOCs per plans.
• Assist in meetings with Regulatory Agencies.
• Coordinate and review responses to queries from Health Authorities to ensure quality.
• Act as back-up contact on multi-discipline teams or with regulatory agencies.
• May lead meetings and provide regulatory input for inspections, audits, and product complaints.
• Support GRL(GRT) by driving high-level project management planning of global submissions and HA interactions.
• Participate in global regulatory team meetings.
• Assist in strategy development by researching regulatory and medical information for submissions.

Connaissances

Regulatory affairs leadership

Submission strategies NDA/MAA/IND

FDA/ICH guidelines

Cross-functional management

Life cycle management

Project planning

Formation

Bachelor's degree in science or equivalent

Description du poste

Jobtailor is seeking an experienced Regulatory Affairs professional in Belgium to lead submissions (NDA/MAA/IND) and ensure alignment with FDA/ICH guidelines. You will coordinate cross-functional teams, manage lifecycle submissions, and support HA interactions throughout the regulatory process.

The role requires a strong track record in global submissions, strategic planning, and leadership within a matrixed organization. Advanced degree and oncology experience are beneficial assets.