Full-Time Associate Director, Regulatory CMC

The Role:We are seeking an Associate Director in Regulatory, CMC who can independently lead, contribute and execute on CMC regulatory activities. The primary responsibility is to generate high-quality and compliant CMC regulatory submissions for global investigational applications, initially focusing on oligonucleotide products.

This position reports to the Senior Director of CMC Regulatory and is a hybrid role based out of our Waltham, MA office.

What You’ll Do:

• Collaborate with CMC cross-functional team members to plan, write, and review CMC sections of pertinent regulatory submissions (e.g., global clinical trial and marketing applications, briefing documents, responses to Health Authorities).
• Provide regulatory guidance to cross-functional team members on required content of Module 2/Module 3.
• Review documentation in support of CMC and QA activities for drug development programs.
• Review and assess proposed CMC changes during drug development for regulatory impact and filing requirements.
• Communicate with regulatory Health Authorities on project-related matters.
• Provide insight and guidance on implementation of current regulations with respect to the preparation and submission of CMC regulatory documentation.
• Review industry guidance and pharmacopoeia updates to ensure cross-functional alignment with current practices and regulations.

Qualifications:

• Education: B.S. in a scientific discipline required; advanced degree a plus.
• Experience: At least 8 years of pharmaceutical industry experience in CMC Regulatory Affairs. Direct experience with development programs through registration is strongly preferred.
• Skills: Demonstrated leadership and track record of regulatory submissions, including effective project management. Experience in preparing high-quality CMC regulatory submissions (Module 2 and Module 3) for global investigational and marketing applications. Strong knowledge of current Good Manufacturing Practices (cGMP), biologics drug development regulations and guidelines including ICH, FDA, and EMA guidelines. Knowledge of eCTD elements and structure. Previous experience leading/supporting interactions with health authorities. Proven ability to manage multiple projects, identify and resolve regulatory issues. Attention to detail and ability to work independently as well as part of a team environment. Excellent organizational and communication skills, both written and verbal. Strong interpersonal skills and the ability to effectively work with others.

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