Foster City

POSTION SUMMARY

Associate Director, CMC Regulatory Affairs is a hands-on and independent role requiring a strong individual who will provide strategic and operational support to multiple programs, with an emphasis on CMC (Chemistry, Manufacturing, and Controls). This role will assist with global clinical trial applications, global marketing applications (including US, Europe, Canada, Rest of World, etc.), and global post approval CMC activities. The position will be responsible for CMC-related submission planning and for ensuring that high‑quality and accurate submission documents are provided within agreed upon timelines. The ideal candidate will need to be able to accurately interpret and discuss data within cross-functional teams and with health authorities.

JOB FUNCTIONS/RESPONSIBILITIES

• Leads and support the development and implementation of CMC regulatory strategy to support global development programs and market applications.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
• Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions (such as Drug Product Development, Drug Substance Development, Analytical/QC, and Quality teams).
• Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.
• Support the preparation of risk assessments on CMC regulatory topics.
• Ensure CMC dossiers meet ICH requirements, as well as country specific requirements.
• Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.
• Support authoring of meeting requests, briefing documents, responses to health authority inquiries, IND/IMPD amendments, post approval changes, and relevant annual updates.
• Review clinical trial label content against country specific requirements.
• Lead or support Health Authority interactions.
• Manage and maintain regulatory CMC tracker and documents.
• Complete other responsibilities as assigned and/or agreed upon.

QUALIFICATIONS

Education/Experience:

• Minimum 8 years of relevant experience in CMC Regulatory Affairs.
• Experience in drug development, market applications and commercial lifecycle.
• Work experience in Regulatory Affairs or related discipline.
• Experience with small molecule regulatory CMC preferred.
• Understanding of multiple drug product dosing forms preferred.
• Experience in preparing CTAs, INDs, , IMPDs, NDAs, MAAs, and Rest of World filings. Knowledgeable of GCP, GXP requirements, ICH, and FDA/EMA guidelines.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Demonstrate ability to manage priorities, multi-task and follow projects through to completion.

Knowledge, Skills and Abilities:

• Use of collaborative workspace (BOX, SharePoint, Veeva, Microsoft Professionals, Adobe, etc.)
• Familiar with navigating to global regulatory websites (ICH, FDA, EMA, etc.)