The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and cell & gene therapies. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains relationships within the Regulatory Affairs functional areas, Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, influence, and provide strategic advice.

Responsibilities:

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations and responds to regulatory information
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Responds to global regulatory information requests.
• Develops strategies for CMC agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation, regulation and guidance, provides analysis to the organization
• Develops, implements, and documents policies and procedures within the regulatory affairs department. Participates in initiatives internal to RA CMC.
  Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
• This role will work a hybrid work schedule (3 days in office & 2 days remote) from the Waltham, MA & Lake County, IL headquarters.  

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required