Senior Manager Regulatory Affairs

Senior Manager CMC Regulatory

• A Partner to Actalent is seeking an experienced Manager of CMC Regulatory Affairs to lead regulatory strategy and execution across both development and commercial programs.
• This role is responsible for ensuring that all Chemistry, Manufacturing, and Controls (CMC) regulatory activities are delivered with scientific rigor, operational excellence, and full compliance with FDA expectations.
• The position requires a seasoned regulatory professional who can navigate complex challenges, drive high‑quality submissions, and collaborate effectively across multidisciplinary teams.
• You will work closely with Quality, Technical Operations, Analytical Development, Formulation, and Program Leadership to guide regulatory strategy, shape submission content, and ensure timely delivery of regulatory filings that support product lifecycle success.

Core Responsibilities

• Regulatory Leadership - Manage all CMC regulatory activities for assigned development and commercial programs, ensuring alignment with project goals and regulatory requirements.
• Cross‑Functional Collaboration - Serve as the regulatory representative on multidisciplinary teams, communicating regulatory objectives, risks, and timelines.
• Submission Strategy - Provide expert guidance on the content, structure, and formatting of U.S. regulatory submissions.
• Document Review - Critically evaluate technical documentation for accuracy, clarity, and adherence to FDA and ICH guidelines.
• Submission Execution - Lead the preparation and review of ANDAs, amendments, supplements, annual reports, and regulatory correspondence.
• Data Analysis - Perform and oversee critical analyses of CMC data, developing sound interpretations and recommendations.
• Quality & Compliance - Ensure completeness, accuracy, and regulatory integrity across all assigned submissions.
• Timeline Management - 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.

Work Environment

• This role operates within a fast‑paced, highly collaborative environment where adaptability, organization, and proactive communication are essential.
• You will work closely with cross‑functional partners to ensure regulatory excellence and support the advancement of key programs.
• The position requires a strong sense of ownership, accountability, and commitment to delivering high‑quality regulatory outcomes.

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 Jul 30, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.