Senior Manager, Regulatory Affairs, CMC

Overview

The Senior Manager, Regulatory Affairs CMC supports the CMC team under the guidance of the Senior Director, CMC. In this role, the Senior Manager provides strategic support and coordination for Chemistry, Manufacturing, and Controls (CMC) regulatory affairs activities. In support of CMC activites, this role is responsible for collaborating closely with cross‑functional teams and regulatory authorities to ensure compliance and drive the success of Shionogi’s pipeline products and initiatives.

• Collaborate with the Senior Director and cross‑functional teams to develop and implement regulatory strategies for CMC aspects of product development. This involves assessing regulatory requirements and guidelines and aligning strategies with business objectives.
• Oversee the preparation, review, and submission of CMC‑related documents for regulatory filings, such as INDs, NDAs, and MAAs. Ensure submissions are of high quality, compliant with regulatory requirements, and submitted within established timelines.
• Serve as a key point of contact for regulatory agencies regarding CMC‑related inquiries, meetings, and submissions. Communicate effectively with regulatory authorities, address queries, and negotiate regulatory matters under the guidance of the Senior Director.
• Work closely with cross‑functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines. Facilitate communication and collaboration among team members to achieve regulatory milestones.
• Stay updated on global regulatory requirements, guidelines, and industry trends related to CMC regulatory affairs. Assess the impact of regulatory changes on product development activities and propose appropriate actions to maintain compliance.
• Maintain accurate and up‑to‑date documentation of regulatory activities, including submission records, correspondence with regulatory agencies, and regulatory intelligence. Ensure compliance with document retention policies and regulatory standards.
• Identify and assess risks related to CMC regulatory affairs and develop mitigation strategies in collaboration with the Senior Director and relevant stakeholders. Proactively address potential regulatory issues to minimize impact on product development timelines.
• Provide support to the Senior Director in various activities, such as preparing for regulatory meetings, conducting regulatory assessments, and contributing to strategic decision‑making related to CMC regulatory affairs.
• Other duties as assigned.

Minimum Job Requirements

• Bachelor's degree in a scientific or related field; advanced degree (e.g., MSc, PhD, PharmD) preferred.
• Minimum of five (5) years of experience in regulatory affairs, with a focus on CMC regulatory affairs in the pharmaceutical industry.
• Strong understanding of global regulatory requirements and guidelines related to CMC aspects of pharmaceutical product development (e.g., FDA, EMA, ICH).
• Excellent communication skills, both verbal and written, with the ability to effectively convey complex regulatory concepts to diverse audiences.
• Demonstrated ability to collaborate effectively with cross‑functional teams and external stakeholders to achieve regulatory milestones and drive product development initiatives forward.
• Meticulous attention to detail and strong analytical skills, with the ability to review and prepare regulatory documentation accurately and ensure compliance with regulatory requirements.
• Proven ability to adapt to changing priorities and timelines in a fast‑paced, dynamic environment while maintaining focus on key objectives and delivering high‑quality results.
• Ethical conduct and commitment to…