Director, US Regulatory Affairs Lead

Shionogi Inc.•Florham Park, NJ

3d•$210,000 - $250,000•Hybrid

About The Position

The Director, Regulatory Affairs leads the development and execution of global regulatory strategies for assigned development programs and U.S. regulatory strategies for marketed products. The role is accountable for integrating regulatory requirements, business objectives, and risk considerations into development plans to support successful product development, regulatory submissions, and lifecycle management. Working independently, the Director serves as the Regulatory Affairs lead for assigned products, partnering with cross-functional teams to provide strategic regulatory guidance, manage regulatory submissions and agency interactions, and ensure timely delivery of regulatory objectives. The Director represents Regulatory Affairs in program-level decision-making, proactively identifies regulatory risks and opportunities, and contributes to the successful advancement and maintenance of development programs while ensuring compliance with global regulatory requirements. A regulatory professional who flourishes in a fast paced environment and enjoys innovative and practical approaches to everyday and complex situations will likely succeed in this position. This role is well suited for a regulatory professional who thrives in a fast-paced environment, embraces continuous improvement, and is motivated to identify practical, forward-thinking solutions to complex regulatory challenges.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, or related scientific discipline required, advanced degree preferred.
Minimum of 10 years of progressively responsible Regulatory Affairs experience within the pharmaceutical or biopharmaceutical industry, including demonstrated experience independently leading regulatory strategy for complex development programs.
Extensive experience supporting U.S. and/or global regulatory strategy across drug development.
In-depth knowledge of U.S. regulatory requirements, supporting complex development programs
Demonstrated experience leading major regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs) and lifecycle management activities
Strong knowledge of global regulatory requirements applicable to drug development.
Demonstrated ability to develop and implement regulatory strategies for complex development programs.
Demonstrated ability to assess regulatory risk and develop practical mitigation strategies.
Strong organizational and project management skills with ability to manage multiple priorities simultaneously.
Ability to operate independently and exercise sound judgment in a fast-paced environment.
Demonstrated ability to develop practical, forward-thinking regulatory strategies by challenging conventional approaches while balancing business objectives with regulatory compliance.
Strong communication and interpersonal skills with ability to collaborate and influence across cross-functional teams and senior leadership.
This position exercises significant independent judgment and regulatory decision-making authority within assigned programs and areas of responsibility.
Ability and willingness to travel approximately 10-15% of the year both domestically and internationally
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Responsibilities

Develops and implements global regulatory strategies for assigned development programs and U.S. regulatory lifecycle strategies for marketed products.
Develops proposals for the evidence package, target indication, population, endpoints, comparators, or other factors that could influence future approvability and labeling
Identifies, evaluates, and communicates regulatory risks, including their probability, impact, mitigations, and acceptable tradeoffs.
Makes or recommend decisions when multiple scientifically or operationally reasonable options exist.
Determines the company’s position on a regulatory question or issue.
Reconciles differing regional needs into an integrated global position.
Interprets regulations, precedents, regulatory feedback, or emerging policy.
Monitors regulatory developments, assessing their impact on development programs and integrating findings into strategic plans.
Represents Regulatory Affairs on cross-functional program teams, offering strategic regulatory guidance to facilitate informed program decisions.
Advises project-team members and functional leaders on regulatory implications, options, and recommendations.
Leads the preparation, review, and submission of regulatory documents.
Ensures all regulatory deliverables are completed in accordance with internal procedures, agreed timelines, and regulatory expectations.
Identifies, evaluates, and communicates regulatory risks, and opportunities devising mitigation strategies to support successful product development and regulatory approvals.
Defines the objectives, key messages, negotiation position, questions, and acceptable outcomes for health-authority interactions.
Establishes the regulatory content, narrative, key claims, and positioning of major submissions and briefing packages.
Leads communications and negotiations with health authorities.
Provides guidance, coaching, and mentorship to less experienced regulatory professionals, supporting knowledge sharing and team capability.
Other duties as assigned.