Sr. Principal Scientist/Sr. Director, Regulatory Affairs Full-time NEW

Senior Principal Scientist (Sr. Director Level), Regulatory Affairs CMC

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.

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, 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

Preferred Skills:

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US and Puerto Rico Residents Only:

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The salary range for this role is

$210,400.00 – $331,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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