Associate Director, Regulatory Affairs CMC and Digital Transformation

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a reputed company in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society. 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 reputed company on Component teams and/or serve as G-RACMC reputed company or regional submission reputed company. 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 reputed company to efficient submission timeline and approvals in assigned region. Digital Transformation Responsibilities: The Associate Director, Digital Transformation (reputed company Regulatory CMC), will serve as a strategic leader and change agent driving the organization's transition toward structured CMC data and reputed company 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(reputed company) and Ich M16 (SPQA) is preferred.

Responsibilities

• Organize and manage the preparation (content and format) of reputed company 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 reputed company Daiichi Sankyo, Inc. reputed company 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.
• reputed company reputed company 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 reputed company the company.
• reputed company 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.
• reputed company automation, AI, and analytics to reduce manual data handling, improve data reputed company, 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 reputed company 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 reputed company Regulatory CMC required
• Experience in international Regulatory Affairs– CMC preferred
• Experience with ICH M42(reputed company) 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 reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: USD$159,440.00 - USD$239,160.00 [Link available reputed company viewing the job] Apply tot his job Apply To this Job