Sr. Principal Scientist/Sr. Director, Regulatory Affairs

About this role

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, ideally including DPI platforms.
• Demonstrated ability to author and coordinate submission content for global health authorities.
• Strong understanding of regulatory requirements and expectations for combination products across major markets.
• Excellent technical writing, communication, project coordination, and stakeholder management skills.
• Direct experience with DPI/MDI combination products.
• Familiarity with FDA, EMA, and other major global regulatory frameworks for inhalation combination products.
• Experience supporting regulatory strategy, lifecycle submissions, and health authority interactions.
• Regulatory certifications such as RAC are a plus.
• Required Skills:
• Combination Products, Combination Products, Confidentiality, Cross-Cultural Awareness, Cross-Functional Teamwork, Drug Regulatory Affairs, Dry Powder Inhalers (DPI), Effective Listening, Electronic Common Technical Document (eCTD), Employee Training Programs, Global Health, Interpersonal Relationships, Process Improvements, Regulatory Advocacy, Regulatory Affairs Compliance, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Documents, Regulatory Interactions, Regulatory Requirements, Regulatory Risk, Regulatory Strategies, Regulatory Submissions, Stakeholder Management {+ 1 more}
• Preferred Skills:
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