Regulatory Affairs Specialist

Colorcon is a world leader in the design and development of specialty excipients for solid oral dosages for the pharmaceutical and nutritional industries. We deliver superior product quality, unparalleled technical support, extensive regulatory assistance, and reliably supply from multiple locations, with our Global Headquarters located in Harleysville, Pennsylvania.

We are a successful company thanks to our diverse workforce and global reach. We believe that our operating principles define our culture, values and organizations and are key to achieving our mission and vision, strategies and goals

Platinum Rule: We treat others the way we want to be treated
Empowerment: We trust our colleagues with responsibility and decision-making
Keep Getting Better: We create an environment for constant improvement, to be the best we can
Teamwork: We embrace the value of collaboration; work together to exceed what is possible as individuals
Customer Focus: We put our customers’ needs at the heart of everything we do
Global Respect: We are citizens of a diverse world and behave with respect for the communities in which we operate

Our People Enjoy a Wide Offering of Employee Benefits, including but not limited to:

• All employees are eligible to participate in our company-wide bonus program
  
• Employees have the choice between three medical plans
  
• 100% company-paid Dental Insurance for all employees and their qualifying dependents
  
• Optional Vision Coverage
  
• Fitness and Wellness Programs
  
• Employee Assistance Programs (EAP)
  
• Corporate Social Responsibility Groups (CSR)
  
• Parental Leave
  
• Tuition Reimbursement; up to $8,000 per calendar year
  
• 401(k) Company Matching
  
• Employees earn up to 17 days of PTO in their first year
  
• Nine Paid Holidays, plus One Personal Holiday for employees to assign at their choosing

Colorcon is committed to maintaining a diverse workforce and an inclusive and equitable work environment. This includes all employment-related decisions and business dealings on the basis of race, color, ethnicity, national origin, age, sex, sexual orientation, religion, disability, veteran status, or any other legally protected status.

Position Summary

The Regulatory Affairs Specialist is a customer-facing position that that works both in the quality and regulatory areas directly managing customer requests for quality and regulatory related information. The position reports to the Regulatory Affairs Manager, and will participate in projects and provide direct support to internal departments including Quality Control and Technical Services.

Responsibilities & Duties

• Manage assigned regulatory and quality customer requests via Colorcon’s Customer Support Solution within expected timeframes for NALAN sites.
• Mentor and support development for the Quality and Regulatory Coordinator(s).
• Provide support and coverage for global regulatory resources at other sites.
• Work collaboratively with internal departments to coordinate customer responses utilizing technical writing and proofreading skills.
• Communicate directly with customers regarding quality and regulatory requests.
• Prepare and present information for customers and internal stakeholders.
• Collaborate with other sites globally to adopt best practices.
• Participate in projects requiring quality or regulatory representation as requested.
• Support internal sales and technical teams.
• Crosstrain in other QA/RA responsibilities as needed.

• Bachelor's degree in a science or related field preferred.
• Minimum of three years' experience in pharmaceutical regulations within quality, regulatory or manufacturing required.
• English fluency required; Bi-lingual in Spanish or French preferred.
• Advanced education in Quality and/or Regulatory studies preferred, with the willingness to pursue required.
• Strong relationship builder and effective communicator.
• Must possess consistent attention to detail.
• Must be proficient with Microsoft Office.

Work Environment:

• 
  Role is based in West Point, PA
  
• This role operates in a professional office environment onsite at a manufacturing facility and is required to be onsite up to 3 days/week or as business requires
  
• 5% Domestic and International Travel Required

Location:
420 Moyer Blvd
North Wales, Pennsylvania, 19486
United States