Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC)

About the role

The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver biologics products to patients, including mAbs, ADCs, and cell & gene therapies. They prepare CMC regulatory strategies that enable first-pass approvals, develop and manage content strategy for regulatory submissions, and build and maintain relationships within the Regulatory Affairs functional areas, Operations, and R&D organizations.

Responsibilities

• Prepares CMC regulatory product strategies and manages regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations.
• Analyzes and interprets information that impacts regulatory decisions and 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, analyzing and approving manufacturing change requests.
• Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, negotiating with and influencing 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, analyzing legislation, regulation, and guidance, providing analysis to the organization.
• Develops, implements, and documents policies and procedures within the regulatory affairs department, participating in initiatives internal to RA CMC.
• Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.

Qualifications

• Required Education: Bachelor's Degree in Pharmacy, Chemistry, Biology, Pharmacology, Engineering, or related field. Preferred Education: Relevant advanced degree preferred.
• Required Experience: 8 years pharmaceutical experience. Preferred Experience: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing.
• Experience developing and implementing successful global regulatory strategies.
• Experience working in a complex and matrix environment.
• Strong oral and written communication skills.

Benefits

Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k).

Pay

$124,500 - $236,500 USD

Schedule

Hybrid work schedule (3 days in office & 2 days remote)