Job Title: Director of CMC Regulatory Affairs
Job Number: 22039
Location: Washington, DC
The incumbent will oversee and direct all global (including U.S.) CMC regulatory support and submissions for late stage development and commercial products. Responsible for developing and implementing innovative CMC regulatory strategies and the preparation and submission of high-quality CMC sections for INDs, IMPDs, CTAs, and original marketing applications (NDAs/MAAs) and subsequent supplements and variations, in close collaboration with in-house Manufacturing and Supply Chain and Quality teams, contract manufacturing organizations, external experts, collaborators, and strategic partners. Liaise with regulatory authorities via written/verbal communication and lead meetings on CMC topics. Maintain a high-level understanding of global regulatory requirements and anticipate the impact of the changing regulatory environment on development and registration strategy.
- Define and oversee the development and implementation of CMC regulatory submission strategy. Identify potential CMC regulatory risks to the strategic/operational plans and propose options to mitigate risks
- Manage the planning, preparation and technical review of CMC regulatory submissions (e.g. Module 3 and QOS) and ensure submissions are completed to meet required/established timelines.
- Provide input to global development teams on CMC regulatory strategies to achieve development objectives. Plan, prepare, review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings
- Liaise with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product progression
- Provides regulatory guidance and support to internal groups such as marketing, quality and manufacturing
- Manage completion of CMC submission documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to eCTD regulatory guidelines, styles and processes
- Interact with regulatory authorities to address CMC regulatory strategy, milestone meetings, queries and regulatory actions
- Minimum BS/BA Chemistry or Biology or Pharmaceutical Science, advanced degree preferred
- RAC (asset)
- Minimum 10 years’ pharmaceutical drug development experience and 5-7 years’ hands-on CMC regulatory experience.
- Minimum of three years in a supervisory/management role
- Solid working knowledge of US and international CMC regulatory (late stage development and commercialization of pharmaceuticals) requirements/processes and the ability to apply knowledge both strategically and operationally to development projects and commercial product regulatory issues
- Strong firsthand experience in development of small molecule products and preparation of Module 3 (CMC sections) of NDAs, MAAs, and INDs.
- Evidence of managing successful CMC submissions with FDA/EMA and demonstrated evidence of writing regulatory documents for both development and commercial products
- Knowledge of eCTD elements and structure and regulatory technical writing skills.