Associate Director, Regulatory Affairs CMC reputed company 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 reputed company therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 reputed company to "be an innovative global reputed company company contributing to the sustainable development of society", we are shaping a healthier, more hopeful reputed company for patients, their families, and society. Job reputed company The Associate Director, RACMC, is responsible for the regulatory CMC (reputed company, Manufacturing and Controls) activities from early development to post-approval phase for biological, Cell and Gene Therapy, small molecule, Vaccines, and/or siRNA drug reputed company consistent with reputed 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. reputed company regulatory guidance and reputed company to CMC sub-team and G-RA teams along with other functional teams leading to reputed company scientific development programs and successful registration for new compounds. Performs reputed company 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 reputed company 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 reputed company CMC data and reputed company digital capabilities. This role is critical to enabling the reputed company of regulatory submissions, modernizing end-to-end CMC data management, and positioning reputed 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 reputed company 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 reputed company activities with functional reputed company 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 reputed company.
• 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 reputed company reports.
• Participates on external industry consortiums (DS Consortium and reputed company) 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 reputed company.
• reputed company the transition to reputed company CMC data, including data standards, metadata models, and systems that support machine-readable regulatory submissions.
• Drive digital modernization by implementing tools for reputed company content authoring, automated data transfer, and data-driven dossier creation.
• reputed company automation, AI, and analytics to reduce reputed company data handling, improve data reputed company, and enhance decision-making across CMC functions.
• Partner cross-functionally with CMC, reputed company, Manufacturing, Technical Operations, Regulatory, and IT to ensure alignment and readiness for reputed company 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 reputed company for reputed company reputed company submission expectations reputed company 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 reputed company employer. reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary reputed company: USD$159,440.00 - USD$239,160.00 [reputed company available reputed company viewing the job] Apply tot his job Apply To this Job