Regulatory Affairs Specialist

Job Responsibilities:

• Collaborate with cross-functional teams, including commercial, medical, legal, and other expertise areas, for review and approval of promotional materials and materials used in scientific exchange for assigned products.
• Work closely with Regulatory Operations in making timely 2253 submissions to OPDP.
• Work closely with regulatory strategy development colleagues regarding proposed product labeling changes to assess and determine the impact on promotional materials.
• Other duties as assigned.

Skills:

• Effective project management skills to oversee the development, review, and approval of promotional materials, ensuring timely submissions and compliance
• Demonstrated ability to manage multiple assignments, appropriately identify regulatory issues, and communicate as needed to management
• Detail-oriented with the ability to promptly assess materials for accuracy as well as consistency
• Excellent organizational skills with the ability to influence, without authority, others positively and effectively

Education:

• Bachelor 's degree in a life science with a minimum of 4 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or Master’s degree in a life science with a minimum of 3 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or Doctoral (M.D., Ph.D., Pharm.D., etc.) degree with a minimum 1-2 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry

Additional Skills & Qualifications

Bachelor 's degree in a life science with a minimum of 4 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry;

This is a Contract position based out of Parsippany, NJ.

The pay range for this position is $50.00 - $52.00/hr.

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 fully onsite position in Parsippany,NJ.

This position is anticipated to close on Apr 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.

Salary : $50 - $52