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Job Summary:
Job Description The Senior Principal Scientist (Sr. Director level), Regulatory Affairs CMC, provides strategic and technical regulatory expertise in support of dry powder inhaler (DPI) combination products across the product lifecycle, from development through registration, approval, and post-approval change management. This individual contributor role is responsible for developing and executing global regulatory CMC strategies, preparing high-quality submission content, and supporting regulatory interactions with health authorities for DPI combination products. The role focuses on ensuring that regulatory plans, submission dossiers, and responses are aligned with global requirements for combination products and inhalation delivery systems.
Key Responsibilities :
Regulatory Strategy and Planning Develop and support global regulatory CMC strategies for DPI combination products. Provide regulatory input into development plans, filing strategies, and lifecycle management activities. Assess regulatory pathways, data expectations, and submission requirements across key markets. Support decision-making by identifying regulatory risks, requirements, and precedent relevant to DPI combination products. Regulatory Submission Support Prepare, review, and revise device-related CMC regulatory content for global submissions, including INDs, NDAs, BLAs, MAAs, and other applicable filings. Author and coordinate regulatory documentation supporting DPI combination products, including module content, summaries, justifications, and technical narratives. Ensure consistency, scientific rigor, and regulatory alignment across submission components. Support timely compilation and delivery of high-quality regulatory dossiers. Health Authority Interactions Support responses to health authority questions, deficiency letters, and information requests related to DPI combination products. Contribute regulatory expertise during meetings, teleconferences, and interactions with global health authorities. Assist in preparing briefing materials, response strategies, and supporting documentation for regulatory engagements. Regulatory Intelligence and Compliance Monitor and interpret evolving global regulatory requirements, guidance, and precedents relevant to DPI combination products. Translate regulatory intelligence into actionable recommendations for development and filing strategy. Support internal alignment on regulatory expectations across functions and regions. Contribute to inspection- and audit-related regulatory readiness activities as needed. Cross-Functional Collaboration Partner with R& D, clinical, manufacturing, quality, and other functions to ensure regulatory input is integrated into product development and submission planning. Provide regulatory guidance to project teams on content, timing, and sequencing of filings. Collaborate with external partners and consultants as needed to support regulatory deliverables. UG, PA. Remote option within US can be considered for highly qualified candidates Less than 20% travel to
US/OUS Education/Skills Required:
Bachelor's degree in pharmacy, Life Sciences, Engineering, Regulatory Affairs, or a related field; advanced degree preferred (M.S., Ph. D). 10+ years of experience in regulatory affairs, preferably with device combination products and inhalation products. Strong experience with global regulatory CMC submissions for combination products, i...
Job Classification:
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