Director of Regulatory

Process Technologies & Packaging - Olyphant, PA

Full-time

Manages Regulatory, Validation and OTC Stability Programs.

· Manages Validation Coordinator

o Provides support for Validation and OTC Stability Programs

· Reviews and approves Validation Documentation (reports, worksheets and summaries)

o Includes IQ, OQ and PQ documentation

· Assists with customer needs on the Validation/Stability programs

o Includes communicating statuses and test results

· Approves design of new Validation Projects

· Responsible for creating and updating Validation Master Plans

· Assists with FDA and customer audits

o Supports requests and concerns as well as requested documentation

· Provides Regulatory guidance and advice to R&D and other internal partners.

· Creates QQ and Ingredient Listing files for Cosmetic and OTC products.

· Manages client needs with raw material suppliers to ensure client/legal compliance.

· Provides support on day-to-day regulatory issues, new initiatives and developments.

· Responsible for authoring department SOPs.

· Responsible for creating and managing finished good SDS files.

· Responsible for managing customer’s international registration requirements.

· Provides weekly updates to VP in regards to regulatory and validation request/projects.

Skills/Qualifications:

· Bachelor's Degree in Chemistry/Biology or related field from accredited college or university

· At least 5 years experience in Cosmetic/OTC Regulatory/Validation environment

· Experience in Manufacturing

· Experience in Management

· Ability to work in a fast paced environment

· Able to read, write and speak English

· Proficient in Microsoft Office applications

Job Type: Full-time

Salary: $60,000.00 to $100,000.00 /year

Experience:

  • relevant: 5 years (Preferred)

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off
  • Flexible schedule

This Job Is Ideal for Someone Who Is:

  • Dependable -- more reliable than spontaneous