Senior Manager – Associate Director, Regulatory Affairs CMC

Shionogi Inc. (U.S.)

Senior Manager/Associate Director overseeing global CMC regulatory strategies for investigational and marketed assets. Collaborating with cross-functional teams to ensure compliance and timely submission of documentation.

Posted 7/14/2026full-timeFlorham Park • New Jersey • 🇺🇸 United StatesSenior💰 $140,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Global CMC Regulatory Strategies, ensuring compliance with Health Authority expectations throughout the product lifecycle. Proficient in managing regulatory submissions and building alignment across cross-functional teams while effectively communicating and influencing stakeholders.

Highest-signal resume keywords

Global CMC Regulatory ExperienceRegulatory Submissions ManagementHealth Authority InterfacingRegulatory Systems ProficiencyStrategic Communication and Influence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory Strategy DevelopmentRegulatory Submission AuthoringChange Control Documentation ReviewRegulatory Assessment and GuidanceLifecycle Management Submissions

Soft Skills

Influencing StakeholdersBuilding Trusted RelationshipsEffective CommunicationNegotiation Skills

Tools & Technologies

Veeva VaultECTD

Certifications & Qualifications

Bachelor’s Degree in Scientific DisciplineAdvanced Degree PreferredRAC (Regulatory Affairs Certification) Preferred

Industry Keywords

CMC Regulatory RequirementsINDs/CTAsNDAs/BLAs/MAAsPost-Approval Lifecycle ManagementRegulatory Training

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Lead development of Global CMC regulatory strategies across the product lifecycle.
Define, prioritize, and execute multiple CMC regulatory activities, recognizing when to escalate decisions, risks, or strategic inflection points to management to ensure alignment and avoid placing CMC on the critical path for approvals.
Track, manage, and coordinate multiple CMC regulatory project timelines, aligning ongoing activities across cross‑functional teams to ensure timely delivery of submission documentation.
Review and approve change control documentation, providing clear regulatory expectations, feedback on supporting data, and guidance on appropriate regulatory pathways or strategies.
Provide regulatory assessment and strategic guidance on CMC documentation for regulatory submissions, including evaluation of development plans, control strategies, labeling content, and Health Authority responses.
Ensure submissions are complete, consistent, and aligned with Health Authority expectations, while effectively navigating regulatory ambiguity.
Author, review, and maintain CMC CTD sections across the product lifecycle, including INDs/IMPDs, NDAs/MAAs/NDSs, and DMF/ASMF/MF submissions, amendments, supplements, variations, and annual reports, ensuring high‑quality, consistent, submission‑ready content delivered in accordance with established timelines.
Serve as the primary CMC regulatory liaison with Health Authorities for designated assets, which involves guiding agency communications, creating briefing documents, handling information requests, and ensuring alignment with management on strategic or high‑risk issues before making commitments.
Builds trusted relationships and influences internal and external stakeholders across global cross-functional teams, including supply chain, manufacturing sites, CMC technical, QA, and CMOs.
Maintain expertise in emerging and evolving CMC regulatory requirements and proactively deliver training and regulatory guidance to Regulatory, Manufacturing and Quality groups on applicable topics.
Able to incorporate AI‑driven tools into CMC regulatory activities, ensuring traceability, and independent verification of information.
Function as a regulatory CMC technical expert for cross-functional teams.
Resolve importation and customs matters for assigned assets, supporting product supply and operational continuity.
Provide support for labeling activities.
Manage and/or support Establishment Registrations, Drug Listings and CARES Act reporting.
Other duties as assigned.

Requirements

What you’ll need

Bachelor’s degree in a scientific discipline
Advanced degree preferred
RAC a plus though not required
A minimum of 5 years (Senior Manager) or 7+ years (Associate Director) of Regulatory Affairs CMC experience in a strategic and operational role
In-depth knowledge of global CMC regulatory requirements across the product lifecycle (development, registration, and post-approval)
Proven hands-on experience with global regulatory submissions (e.g., INDs/CTAs, NDAs/BLAs/MAAs) and accountability for post‑approval lifecycle management submissions.
Demonstrated ability to effectively communicate, influence, and negotiate CMC regulatory strategies while building alignment across management and cross-functional teams.
Prior experience interfacing with Health Authorities on CMC-related topics.
Proficiency with regulatory systems (e.g., Veeva Vault, eCTD, etc.).

Benefits

Comp & perks

Health insurance
Retirement plans