Regulatory Affairs Professional (Product Regulatory Expert)

Our client is a global specialty materials company committed to enhancing the quality of life through innovative products and solutions, prioritizing safety and sustainability. With a focus on key sectors such as transportation, building and construction, and consumables, it leverages cutting-edge technology platforms, fosters deep customer engagement, and drives differentiated application development to maintain its leading positions in these markets. As a globally inclusive and diverse company, they have employed approximately 14,000 people around the world and serves customers in more than 100 countries.

Responsibilities:

• Work closely with Quality Assurance to obtain regulatory documentation required to maintain drug master files (DMFs)
• Prepare and submit annual updates and amendments for DMFs to global regulatory agencies in accordance with the regulatory agencies’ guidelines.
• Engage with and monitor external consultants utilized for submissions.
• Track regulatory submissions to ensure timely filings in accordance with regional regulatory requirements.
• Maintain regulatory records, including archiving of regulatory submissions.
• Work closely with Product Stewards, Quality and project teams to outline regulatory requirements, costs, and timelines for new DMFs required to support new or expanding products.
• Acquire in-depth knowledge of company current and developing portfolio of products used in the regulated markets mentioned above in order to answer compliance related questions from internal partners,
• external parties, and add value to existing and new customer engagement discussions.
• Maintain awareness of global regulatory legislation and its impact on company products and business
• Provide appropriate information to promote the safe use of company products throughout their entire life-cycle to:
• External Stakeholders – including customers, distributors, and industry partners
• Internal Stakeholders - including Product Stewards and SMEs, manufacturing, technology, product management, and sales & marketing personnel
• Develop/maintain a sound awareness of global trends in pharmaceutical regulations.
• Prepare responses for customer inquiries.
• Execute reviews/approvals for new product reg tox and commercialization requests related to applications in regulated markets.
• Assist with special projects related to Product Stewardship & Regulatory Affairs, as needed.
• Learn other areas within the Food, Drug, Device, Cosmetic (FDDC) Regulations to provide support to the FDDC team.

Requirements:

• Minimum of Bachelor’s degree (or higher) required.
• 2 – 5+ years of experience in a regulatory affairs role.