Manager, Regulatory Affairs-Chemistry Manufacturing & Controls (CMC)

AbbVie is seeking a Manager, Regulatory Affairs-Chemistry Manufacturing & Controls (CMC) to ensure RA-CMC post approval change objectives are met by project managing marketed product variations. The position will also ensure proper communication with key partners in functional departments in support of regulatory filings.

Requirements

• Independently manage, compile, and author CMC sections of marketed product variations.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines 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.
• Provide coaching to more junior RA CMC colleagues during team and management reviews.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Develop and utilize current best practices for use of regulatory business systems within the group.
• Identify and communicate content gaps and risks for variation documents.
• Coach, mentor, and develop junior staff.
• Provide guidance on use of submission document templates.
• Support annual reports and renewals (ad hoc baseline support)

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)