Associate Principal Scientist; Assoc. Director), Regulatory Affairs - CMC

Job Description

GRACS (Global Regulatory Affairs & Clinical Safety) CMC – Associate Principal Scientist, CMC – Pharm Pre-approval (Respiratory/Inhalation Products)

This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance, with a focus on small molecule respiratory/inhalation product development. Position will support respiratory/inhalation and some conventional small molecule programs and is responsible for the preparation and submission of CMC dossiers.

Primary responsibilities include, but are not limited to:

• Regulatory CMC responsibilities:
  Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead development and execution of global product and project regulatory strategy(ices) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.
• Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to GRACS CMC management, as needed.
• Interpret and communicate regulatory expectations to internal and external stakeholders (including partners, CRO/CMOs) to execute program objectives in compliance with applicable regulations.
• Partner with quality colleagues to prepare for and support pre-approval and regulatory inspections, ensuring launch readiness and regulatory success.
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our Company's pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry

• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• The candidate must be proficient in English; additional language skills are a plus.

• The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Regulatory CMC experience with complex drug-device combination products/inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required.
• Preferably, the candidates should be familiar with the latest global regulatory guidance and pharmacopeial methods with a demonstrated ability to apply them to build regulatory strategies related to Inhalation products.
• The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• They must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
• The candidate must have excellent interpersonal, verbal, and written communication, presentation, and listening skills with a proven…