Sr Manager Of Regulatory Affairs/CMC

Core Responsibilities

• Manage all CMC regulatory activities for assigned development and commercial programs, ensuring alignment with project goals and regulatory requirements.
• Serve as the regulatory representative on multidisciplinary teams, communicating regulatory objectives, risks, and timelines.
• Provide expert guidance on the content, structure, and formatting of U.S. regulatory submissions.
• Critically evaluate technical documentation for accuracy, clarity, and adherence to FDA and ICH guidelines.
• Lead the preparation and review of ANDAs, amendments, supplements, annual reports, and regulatory correspondence.
• Perform and oversee critical analyses of CMC data, developing sound interpretations and recommendations.
• Ensure completeness, accuracy, and regulatory integrity across all assigned submissions.
• Plan, prepare, and deliver regulatory documentation in alignment with aggressive project timelines.

Essential Qualifications

• Advanced degree in a life science discipline (Ph.D., M.S., or equivalent).
• 10+ years of pharmaceutical industry experience, including 8+ years in CMC-focused Regulatory Affairs.
• Proven managerial experience with demonstrated success developing and leading regulatory teams.
• Strong written, verbal, and negotiation skills with the ability to articulate complex scientific and regulatory concepts.
• Deep understanding of pharmaceutical development, CMC regulatory frameworks, and FDA/ICH guidelines.
• Ability to prioritize, multi-task, and operate effectively in a fast-paced environment.
• Strong critical thinking, problem-solving, and decision-making capabilities.
• Highly organized, self-motivated, and able to work independently.

Additional Skills & Attributes

• Sound Judgment - Ability to make informed decisions in complex or ambiguous situations.
• Effective Communication - Skilled at influencing and collaborating across scientific and operational functions.
• Team Leadership - Demonstrated ability to build, mentor, and elevate high-performing regulatory teams.

Job Type & Location

This is a Permanent position based out of Morristown, NJ.

Pay And Benefits

The pay range for this position is $150000.00 - $160000.00/yr. Will share specifics during the interview process. Will be getting holiday, and PTO packages.

Workplace Type

This is a fully onsite position in Morristown, NJ.

Application Deadline

This position is anticipated to close on Aug 11, 2026.