Regulatory Operations Senior Manager
Job Summary
We are seeking an experienced Senior Manager of Regulatory Operations to lead regulatory strategy development and oversee day-to-day operational activities, ensuring compliance and strategic alignment across global markets.
Key Responsibilities
Develop and execute innovative drug regulatory strategies
Manage daily operations using project management and planning tools; maintain detailed project timelines
Provide regulatory advice on key development issues and communicate with stakeholders
Review client programs at a high level and develop strategic plans for clinical, analytical, and process development
Ensure compliance with ICH and local regulatory requirements across development programs
Initiate, author, and collaborate on SOPs, work instructions, and workflows for regulatory operations, including eCTD submissions and post-marketing compliance
Author and oversee regulatory documents (CMC authoring) for submissions and messaging
Collaborate closely with development teams to align regulatory, CMC, and labeling strategies for pharmaceutical/biological products
Serve as primary liaison between company and regulatory agencies
Strategize EU expansion roadmap, including MAA planning, submission types, country selection, and setup of EU QPPV office
Desirable Skills and Experience
10–15 years of experience in a regulated life sciences environment
Strong project management and interpersonal skills
Business development experience
Expertise in organizational strategy, process and change management, KPIs, resource forecasting
Extensive knowledge of global submission standards (FDA, HC, EMA, ICH, eCTD) and dossier preparation (IND/CTA/NDA/MAA)
Experience with regulatory change management and operations
Knowledge of RoW markets and medical device regulations (a plus)
Familiarity with eCTD publishing systems, TRS toolbox, and related tools
Deep understanding of regulatory information management and operational priorities across business areas
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