Global Program Regulatory Manager (Remote)

Role Summary

The Global Program Regulatory Manager (GPRM) leads strategic and operational regulatory direction for programs through development, registration, and post-approval, working with the global RA program team and/or Global Therapeutic Area Lead. The GPRM ensures execution of regulatory plans in line with global regulatory strategy, and may act as the GPT representative in certain cases. The role is part of the RA sub-team and may lead regional RA sub-teams.

Responsibilities

Regulatory Strategy

• Provide input to global program regulatory strategy, including regulatory designations and innovative approaches.
• Coordinate regulatory readiness with other line functions, Country Organizations & Regions, representing Regulatory Affairs or leading in regional RA or cross-functional activities, providing strategic input into cross-functional deliverables.
• Contribute to the development and maintenance of key documents, determine requirements, and coordinate activities for Health Authority interactions.

Regulatory Submissions

• Lead planning, preparation, and submission of clinical trials.
• Lead implementation of the defined global registration strategy into regional submissions worldwide by country organizations.
• Coordinate, plan, and prepare for submission of initial registrations and post-approval applications, and the preparation, review, and maintenance of local product information as assigned.
• Lead regulatory activities during HA reviews, responding to questions and HA interactions.

Regulatory Excellence & Compliance

• Ensure timely RA input and submission of regulatory compliance and maintenance reports, maintaining regulatory information in compliance databases and document management systems.

Qualifications

• Experience with regulatory submission and approval processes in one or more major regions.
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
• Experience in HA negotiations.
• 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV.
• Innovation in regulatory strategy; understanding of post-marketing/brand optimization strategies and commercial awareness (preferred).
• Involvement in dossier submissions and approvals.
• Drug regulatory submission and commercialization in region.
• Analysis and interpretation of efficacy and safety data.
• Regulatory operational expertise.

Education

• Science-based BS or MS with requisite experience; advanced degree (MD, PhD, PharmD) preferred.

Skills

• Strong interpersonal, communication, negotiation and problem-solving skills.
• Basic organizational awareness (e.g., interrelationship of departments, business priorities).

Additional Requirements

• Location: East Hanover, NJ site is ideal, but remote work may be possible; relocation is not provided. If remote, home office expenses and travel/lodging to East Hanover for periodic live meetings are at the employee's expense. Working hours and travel (domestic and/or international) will be defined by the hiring manager.