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Daiichi Sankyo US · 21 hours ago

Associate Director, Regulatory Affairs CMC and Digital Transformation

Basking Ridge, NJ

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$159K/yr - $239K/yr

7+ years exp

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies. The Associate Director, Regulatory Affairs CMC and Digital Transformation, is responsible for regulatory CMC activities and driving the organization's transition toward structured CMC data and digital capabilities.

Health CareTherapeuticsWellness

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Organize and manage the preparation (content and format) of all types of submissions to Health Authorities

Coordinates activities required for timely and accurate reporting of information to existing submissions

Supervise the identification and compilation of required documentation for submission

Prioritizes workload. Evaluate content and adequacy of submissions and identify deficiencies against regulatory guidance’s or internal data bases

Facilitate and support liaison activities with functional groups within Daiichi Sankyo, Inc. related to assigned products/project areas such as the clinical supplies organization, Reg Operations, Medical Affairs and labelling

Participates in meetings with Health Authorities

Prepares internal functional teams for these interactions to build strong relationships with FDA and secure successful meeting outcomes

Coordinates preparation, authors, and finalizes meeting materials to include meeting requests, briefing books and meeting minutes

Keep current with Regulatory guidelines and assists in educating the organization on evolving Regulatory Affairs CMC (RACMC) issues and regulations through internal technical seminars, global forums or trip reports

Participates on external industry consortiums (DS Consortium and Biophorum) to understand industry standards and contribute to policies and or standards. Identifies areas for process /procedure improvements and works on improvement implementation

Provides training on evolving regulations. This could involve Global RACMC teams or cross-functional initiatives within the company

Lead the transition to structured CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions

Drive digital modernization by implementing tools for structured content authoring, automated data transfer, and data-driven dossier creation

Enable automation, AI, and analytics to reduce manual data handling, improve data integrity, and enhance decision-making across CMC functions

Partner cross-functionally with CMC, Quality, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for structured data capabilities

Manage organizational change, including capability building, training, and communication to support adoption of new digital processes

Monitor global regulatory and industry trends and lead internal initiatives that position the company for future structured submission expectations and digital regulatory innovations

Qualification

Regulatory Affairs CMCDigital TransformationInternational Regulatory AffairsICH M42(R2)ICH M16 (SPQA)Life Science DegreePharmDTrainingCollaborationCommunication

Required

Bachelor's Degree Life Science Degree required

7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required

Experience in Digital Transformation within Regulatory CMC required

Preferred

Master's Degree preferred

PharmD preferred

Experience in international Regulatory Affairs– CMC preferred

Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred

Ability to travel up to 10% of the time

Company

Daiichi Sankyo US

Glassdoor4.0

Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.

Founded in 2005

Basking Ridge, New Jersey, USA

10001+ employees

https://daiichisankyo.us

H1B Sponsorship

Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (32)

2024 (25)

2023 (19)

2022 (12)

2021 (7)

2020 (6)