Principal Scientist; Director), Regulatory Affairs-CMC

Overview

GRACS CMC – Principal Scientist, CMC, – Pharm Pre-approval (Inhalation/Respiratory Franchise). Reporting to the Ex-Director/Sr. Director in Pre-approval Pharmaceutical CMC, this role is responsible for developing and implementing CMC regulatory strategies for the Company's pipeline products in accordance with global regulations and guidance, with a focus on small molecule respiratory/inhalation product development. Position will primarily lead oversight of multiple programs in the Respiratory franchise and some conventional small molecule programs.

• Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule development products, including preparation of applicable IND/CTA’s, Agency Background Packages, Worldwide Marketing Applications (including Most of World applications), and transfer strategy to post-approval groups for submissions in major markets.
• Directly support projects in a similar capacity; primary focus is directing team members responsible for regulatory strategies and submissions, ensuring high quality and likelihood of approval; assess CMC changes, define regulatory requirements, develop CMC regulatory strategies, manage regulatory risk and business impact, use regulatory intelligence, and adapt to changing regulations.
• Communicate regulatory risks, challenges, and opportunities to management; develop and oversee regulatory initiatives and strategies of significant complexity; collaborate with Senior Leadership and cross-functional teams; embody company values.
• Develop and manage talent within the team; succession planning; promote collaboration; set vision and enforce policies; manage resources and prioritization; sponsor employees; build relationships with stakeholders; represent department in senior forums; maintain expert knowledge of global CMC requirements for IND/CTA and registrations; identify and resolve problems; adapt to fast-paced environment; ensure SOP adherence; partner with Quality to prepare for inspections; drive continuous improvement.
• Drive innovative and scientifically sound approaches to gain approval of new products; participate in development of CMC processes; lead Regulatory CMC discussions with agencies; maintain expert knowledge of industry whitepapers and guidance; present at industry meetings.

• Education Minimum Requirement:
  Master s degree in chemistry, Pharmacy, or related discipline; post-graduate degree preferred.
• Required
  
  Experience and Skills:
  
  Minimum 15 years pharmaceutical industry experience; 10 years with advanced degree; minimum 5 years in Regulatory CMC including product lifecycle development; minimum 3 years managing people.

• Strong technical leadership in Regulatory CMC with understanding of pharmaceutical operations and experience managing a Regulatory CMC team.
• Experience with complex drug-device inhalation products (nebulizers, dry powder inhalers, metered-dose inhalers) and knowledge of global regulatory guidance and pharmacopeial methods for inhalation products.
• Understanding of characterization studies and analytical methods for inhalation products.
• Creativity in problem solving, ability to adapt to changing priorities, deep experience defining global Regulatory CMC strategy, collaboration, rapid decision-making, and working under pressure.
• Excellent interpersonal, verbal and written communication, presentation, and collaboration with multi-disciplinary teams; experience building and retaining talent.
• Proven ability to critically review scientific information and draw concise conclusions; proficient in English; additional languages a plus.

Required Skills: Audits, Compliance, CMC Development, Data Integrity, Documentation, Dry Powder Inhalers (DPI), Employee Training Programs, Organizational Optimization, Pharmaceutical Process Development, Pharmacology, Production Optimization, Product Lifecycle, Regulatory CMC, Regulatory Compliance, Regulatory Experience, Technical Writing.

Current employees apply HERE. Current contingent workers apply HERE. US and Puerto Rico residents only. Our company is committed to inclusion; accommodations available during application process.

Equal Employment Opportunity:
We provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. For more information about personal rights under US EEO laws, visit EEOC Know Your Rights and EEOC GINA Supplement.

Job Posting End Date: 02/18/2026. Requisition : R383317.