Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Job Summary
The Associate Director, RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug projects consistent with the company goals. Participate on G-RACMC teams and support or lead on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other functional teams leading to sound scientific development programs and successful registration for new compounds. Performs collaborative authoring with other RACMC regional team members and subject matter experts for Health Authority (HA) submission, HA meetings, and responses to HA queries. Support company goals to building filing strategies that lead to efficient submission timeline and approvals in assigned region.
Digital Transformation Responsibilities: The Associate Director, Digital Transformation (within Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and next-generation digital capabilities. This role is critical to enabling the future of regulatory submissions, modernizing end-to-end CMC data management, and positioning the company for global competitiveness in an increasingly data-driven biopharmaceutical landscape. Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
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.
Qualifications
Education Qualifications
- Bachelor's Degree Life Science Degree required Master's Degree preferred PharmD preferred
Experience Qualifications
- 7 or More Years in the pharmaceutical industry with significant experience in scientific/regulatory fields required
- Experience in Digital Transformation within Regulatory CMC required
- Experience in international Regulatory Affairs– CMC preferred
- Experience with ICH M42(R2) and Ich M16 (SPQA) is preferred.
Travel Requirements
- Ability to travel up to 10% of the time.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Salary Range:
USD$159,440.00 - USD$239,160.00