Manager Regulatory Operations

Scientific Search; Montgomeryville (Montgomery County); On-site; USD 70,000 - 110,000; Full time

Job summary

Scientific Search is seeking a Regulatory Affairs professional to establish and maintain regulatory operations for cosmetics, OTC pharma, and medical device products under MoCRA. You will ensure current FDA registrations and listings, monitor regulatory changes, and manage customer regulatory tasks.

Ideal candidate holds a BA/BS in a science or engineering field with 3-8 years in a cGMP environment, and relevant certifications are preferred. Occasional travel to client sites may be required.

Qualifications

• BA/BS in a relative scientific or technical discipline.
• Experience in a cGMP environment and related QA or Regulatory field.
• Certification such as Certified Quality Auditor or Regulatory Affairs preferred.

Responsibilities

• Establish and maintain the regulatory operations program, including procedures for FDA product listings for cosmetics under MoCRA, OTC pharma and medical device products.
• Ensure registrations/listings are current: FDA Establishment Registration, FDA Cosmetic Product Listings, FDA Medical Device Listings, FDA OTC NDC Listings, FDA Annual Volume reporting, State Licenses.
• Monitor regulatory landscape and provide current regulatory assessments to site management, communicating compliance risks and developing action plans for changes.
• Establish and maintain processes for managing customer Regulatory and Compliance related tasks.
• Assist customers in completing documentation to support global product registrations and supply CDMO documentation; review and complete Quality Agreements to ensure a consistent approach across the client’s portfolio.

Skills

Regulatory affairs

GMP compliance

cGMP

MoCRA / FDA regulations

Documentation

Quality Assurance

Interpersonal communication

Education

BA/BS in science or engineering

Job description

Our client is a global contract development and manufacturing partner for beauty, personal care and healthcare brands. They develop and manufacture some of the world’s greatest products for global CPGs, emerging brands.

Overview

• Establish and maintain clients regulatory operations program, including establishment of procedures for handling FDA product listings for cosmetics under the MoCRA legislation, OTC pharmaceutical and medical device products and other listings as required by regulators in the markets that we serve.
• Ensure all registrations and listings are completed and maintained as current, including:
  • Annual FDA Establishment Registration - Cosmetic, OTC and Medical Device
  • FDA Cosmetic Product Listings
  • FDA Medical Device Product Listings
  • FDA OTC NDC Product listings
  • FDA Annual Volume reporting
  • State Licenses
• Monitor the regulatory landscape and ensure that site management is provided with current regulatory assessments of existing and emerging regulations, ensure that compliance risks are communicated in a timely manner, and develop action plans to address any changes that impact the quality system.
• Establish and maintain a process for managing customer Regulatory and Compliance related tasks.
• Responsible for managing customer Regulatory and Compliance related tasks, including:
  • Assist customers in the completion of documentation that supports global product registrations.
  • Supply CDMO documentation to customers that supports global product registrations
  • Review and completion of Quality Agreements to ensure a consistent approach across the client’s portfolio.

Requirements

• BA/BS in relative scientific or technical discipline field
• Preferred area of study: Science or engineering, biological sciences
• Experience in a cGMP environment and related Quality field, 3-8 years
• Certification such as Certified Quality Auditor or Regulatory Affairs Certificate preferred
• Knowledge of relevant GMP regulations: FDA 21 CFR 210, 211,1, ICH 13485, 21CFR820, familiarity with FDA procedures and MoCRA legislation.
• Strong focus on continuous improvement and quality, willing to work with others in a fast-paced environment, conscious of the need to implement improvements as a team
• Strong interpersonal communication, ability to write in a clear, concise manner

Travel

Occasional travel between clients local sites

Education And/or Experience

• BA/BS Degree in relative science or technical discipline field, preferably Science or Engineering. Experience in a cGMP environment and related QA or Regulatory field, 3-8 years.

The client offers a competitive salary package that is dependent on qualifications and experience, as well as a strong benefit package, plus participation in a company-wide bonus plan.

Please note that all candidates applying must be a US Citizen or Permanent Resident. Client will NOT sponsor.