At least 10 years
Job Title: Manager CMC Regulatory
The role involves ensuring that CMC regulatory activities are conducted effectively to support both pre and post-approval submissions. You will be responsible for maintaining high quality standards while adhering to aggressive timelines. The position requires solving complex problems by analyzing various factors and ensuring that regulatory files and data systems comply with relevant work instructions and regulations. Collaboration with functional groups is essential to plan, author, compile, and submit high-quality original applications, amendments, supplements, and responses to FDA inquiries.
Responsibilities
- Manage all regulatory activities associated with development projects.
- Participate in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects.
- Provide guidance to teams on the content, format, style, and architecture of US submissions for assigned submissions.
- Critically review documentation intended for submission to the FDA for internal consistency and adherence to relevant FDA guidelines.
- Organize, prepare, and review new ANDAs, amendments, supplements, annual reports, and other regulatory documents and correspondence.
- Perform and manage critical analyses of data and independently develop interpretations and conclusions for discussion with regulatory management.
- Ensure the completeness and accuracy of all assigned regulatory submissions.
- Plan, prepare, and submit regulatory documentation according to planned timing.
Essential Skills
- Advanced degree in a life science.
- Minimum of 10 years of pharmaceutical industry experience, with at least 8 years in Regulatory Affairs focusing on CMC.
- Managerial experience is required.
- Excellent written, verbal, and negotiation skills.
- Ability to effectively articulate complex project-related matters.
- Advanced understanding of pharmaceutical development and CMC regulatory affairs, including regulatory guidelines and federal regulations.
- Strong ability to prioritize, multi-task, and work in a fast-paced and dynamic environment.
- Strong critical and logical thinking skills with the ability to analyze problems.
- Highly organized and self-motivated.
- Demonstrated success in developing fully functional regulatory teams.
- Ability to exercise sound judgment and make sound decisions on regulatory activities, strategies, and work outputs.
Additional Skills & Qualifications
- Exhibits sound judgment and decision-making abilities.
- Ability to exercise effective communication with multidisciplinary teams.
Work Environment
The position requires working in a dynamic and fast-paced environment where prioritization and multitasking are essential. The role involves collaboration with various functional groups to ensure regulatory excellence. The work setting encourages a high level of organization and self-motivation.
Job Type & LocationThis is a Permanent position based out of Morristown, NJ.
Pay and BenefitsThe pay range for this position is $140000.00 - $165000.00/yr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
This is a hybrid position in Morristown,NJ.
Application DeadlineThis position is anticipated to close on Jun 15, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
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.
Posting ID: JP-006061874
