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).

Key Responsibilities

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.

Qualifications Experience and Skills

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.

Leadership Capabilities

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.

Required Skills

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Fact‑Based Decision Making

Industry Analysis

Legal Support

Process Improvements

Product Licensing

Public Policies

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