Associate Director, RA-CMC PAC DM

About the Role

Individual is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. This position will manage, coach, mentor, and develop junior staff, including new employee onboarding.

Key Responsibilities

• Independently manage, compile, and author CMC sections of marketed product variations. Update moderately complex CMC documents independently.
• Independently develop initial content plans, bundling strategies, and project timelines. Partner with RA CMC Project Leads to verify and finalize as needed.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Drive team and management reviews with minimal intervention by project lead. Provide coaching to more junior RA CMC colleagues during team and management reviews.
• Lead business critical programs through coordination of activities and resource management across global programs for multiple post approval changes.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met consistently across projects. Develop and communicate/train on best practices for use of regulatory business systems within the group.
• Independently provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
• Identify and communicate content gaps and risks for variation documents.
• Provide usage team guidance and drive updates to submission document templates.
• Support annual reports and renewals (ad hoc baseline support).

Qualifications

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline.
• Required: 8 years pharmaceutical experience. Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing, 2-plus years supervising employees.
• Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions.
• Strong working knowledge of manufacturing unit operations or CTD structure.
• Superior oral and written communication skills.
• Ability to work cooperatively with all levels and types of global personnel required.
• Experience working with electronic document management systems.
• Ability to work independently under pressure and manage multiple projects simultaneously.
• Detail/accuracy oriented.
• Collaborative and willing to learn.
• Familiarity with US and other international regulatory requirements for drug product dossiers.

Pay & Benefits

Compensation range based on job grade and geographic location. Eligible employees receive a comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k). This job is eligible to participate in long-term incentive programs.