Senior Manager / Associate Director, Regulatory Affairs CMC

Shionogi Inc.•Florham Park, NJ

23h•$140,000 - $200,000•Hybrid

About The Position

The Senior Manager/Associate Director, Regulatory Affairs CMC is a strategic and hands on regulatory contributor responsible for defining and executing global CMC regulatory strategies for assigned investigational and/or marketed assets. The role partners closely with technical, quality, supply and program teams to communicate regulatory strategies and deliver scientifically sound, submission ready CMC content using a risk based approach. This individual demonstrates exceptional scientific writing, precision, and attention to detail, applies creative thinking and a collaborative, high quality approach that ensures data integrity, regulatory compliance, and trust with cross functional partners and health authorities.

Requirements

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.).
In‑depth knowledge of global regulatory CMC requirements for advanced therapies and/or biologics across the product lifecycle, including development, registration, and post‑approval change management.
Solid understanding of the downstream development and commercialization implications of regulatory CMC decisions, enabling risk‑based, phase‑appropriate regulatory strategies.
Strategic and hands on regulatory leader, able to independently develop regulatory CMC approaches and proactively align with regulatory leadership and management obtaining agreement on strategy prior to communication or implementation with cross‑functional teams.
Established record of leading cross‑functional CMC teams, coordinating complex activities within a matrixed environment, and exercising full ownership for the writing, quality, and delivery of regulatory CMC submissions, and responses to Health Authorities.
Demonstrated success engaging with Health Authorities on CMC-related topics.
Advanced scientific writing skills, with a strong focus on compliance, quality, and data integrity, ensuring the regulatory CMC submissions align with global regulatory requirements.
Excellent verbal communication skills, with demonstrated ability to act as a regulatory CMC spokesperson and effectively communicate aligned regulatory CMC strategies and positions across working teams, cross‑functional forums, and senior leadership.
Proven capability to assess regulatory risk and make informed decisions independently, with clear judgment on when to escalate complex or high‑risk CMC issues.
Ability to mentor and develop others.
High level of proficiency in Microsoft Office (Word, Excel, PowerPoint), enabling development of high‑quality regulatory documents, data summaries, and executive‑level presentations with minimal supervision.

Nice To Haves

Advanced degree preferred.
RAC a plus though not required.

Responsibilities

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.