Manager Global Regulatory Scientist, Regulatory Affairs

Manager Global Regulatory Scientist, Regulatory Affairs

Location:

Beerse, Antwerp, Belgium;
Leiden, South Holland, Netherlands;
High Wycombe/Maidenhead, UK;
Raritan, NJ;
Spring House, PA (USA).

• Draft cover letters and support the preparation of various applications (e.g., IND, CTA, MAA/NDA, eCTD) and procedures for regulatory agency submissions.
• Ensure protocols for CTA/INDs align with regulatory requirements and advise on required documents and submission strategies.
• Provide regulatory support throughout the registration process for Marketing Authorization Applications (NDA, MAA, or other major HA submissions).
• Advise team on required documents and submission strategies for NDA, MAA, and other global filings in collaboration with LOCs as appropriate.
• Assist with timely availability of NDA/MAA documents, ensuring all components are in place on time, and identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications.
• Ensure country‑specific submission packages are made available to the LOCs in accordance with agreed plans.
• Prepare for meetings with regulatory agencies; coordinate, contribute to development, and review the content of responses to queries from HAs.
• Liaise with LOCs and track submission and query response dates.
• Act as backup contact/representative on specific multidisciplinary teams or with regulatory agencies as needed; may organize and lead meetings.
• Provide regulatory input and appropriate follow‑up for inspections, audits, litigation support, and product complaints.
• Support GRL(GRT) by driving project management planning of global submissions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information for submissions to global health authorities.
• Advise the regulatory team on applicable regulatory requirements and project‑specific regulatory issues.
• Partner with regulatory colleagues to understand the competitive landscape, regulatory precedents, labeling differences, and disease‑area‑specific issues.
• May assist in developing and improving regulatory processes.

• A Bachelor's degree in a scientific or equivalent discipline; an advanced scientific degree is preferred.
• At least 6 years of health‑regulated industry experience; or a Master’s degree with a minimum of 5 years; 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 is ideal.
• Solid understanding of FDA and ICH regulatory requirements and guidelines for clinical research, product development, life‑cycle submission management, and product labeling is required.
• Therapeutic area experience in oncology is beneficial; experience with combination products (drug and device) is an asset.
• Intellectual curiosity and flexibility to learn new things and work in novel areas with limited regulatory precedence.
• Experience preparing responses to health authorities, managing authority interactions, and life‑cycle management of clinical trials and marketing authorizations.
• Experience in strategic planning, technical data summary, and cross‑functional management is required.

• Strong organizational and time‑management skills.
• Strong collaboration skills, including effective communication and conflict‑resolution skills.
• Strong leadership capabilities and ability to work successfully in a matrixed environment.
• Effective critical thinking, including problem‑solving and goal‑setting.
• Demonstrated ability to think strategically and contingency‑plan to meet business objectives.
• 10% domestic travel and potential international travel may be required.

• Analytical Reasoning
• Business Writing
• Coaching
• Compliance Risk
• Fact‑Based Decision Making
• Industry Analysis
• Legal Support
• Process Improvements
• Product Licensing
• Public Policies
• Re…