Regulatory- CMC , Manager

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.

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

The 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.

This position is anticipated to close on May 8, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $140,000 - $165,000