Job Information
Actalent Sr. Manager CMC Regulatory in Morristown, New Jersey
Description
Ensures that appropriate CMC regulatory activities occur in support of both pre and post-approval submissions while meeting aggressive timelines and adhering to the highest quality standards. Works on and solves increasingly complex projects/problems where analysis of the situation or data requires evaluation of some intangible factors. Ensures that regulatory files and data systems are maintained and in compliance with related work instructions and regulations. Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA.
Skills
cmc, anda
Top Skills Details
cmc,anda
Additional Skills & Qualifications
• Advanced degree in a life science. • Minimum of 10 years of pharmaceutical industry experience, at 8+ years in Regulatory Affairs with emphasis on CMC. Must have managerial experience. • Exhibits excellent written, verbal and negotiation skills. Must be able to effective articulate complex project related matters. • Advanced understanding of pharmaceutical development and CMC regulatory affairs including regulatory guidelines, federal regulations and legal considerations. • Strong ability to prioritize, multi-task and work in a very fast paced and dynamic environment. • Strong critical and logical thinker with ability to analyze problems. • Highly organized and self-motivated. Demonstrated successes at developing fully functional regulatory teams. • Able to exercise sound judgement. Demonstrated ability to make sound decisions on regulatory activities, strategies and work outputs. 1. Manages all regulatory activities associated with Alvogen development projects, as assigned. 2. Participates in multidisciplinary project teams to provide regulatory guidance and communicate regulatory goals for assigned projects. 3. Provides guidance to multidisciplinary teams on the content, format, style and architecture of US submissions for assigned submissions. 4. Critically reviews documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA guidelines and to promote regulatory excellence. 5. Manages the organization, preparation and review of new ANDAs, amendments, supplements, annual reports and other regulatory documents and correspondence, as assigned. 6. Performs and manages critical analyses of data and independently develops interpretations and conclusions for discussion/consideration with regulatory management. 7. Ensures the completeness and accuracy of all assigned regulatory submissions. 8. Responsibility for the planning, preparation and submission of regulatory documentation according to planned timing.
Experience Level
Expert Level
Job Type & Location
This is a Permanent position based out of Morristown, NJ.
Pay and Benefits
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)
Workplace Type
This is a hybrid position in Morristown,NJ.
Application Deadline
This position is anticipated to close on May 1, 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.