Regulatory Affairs Specialist

Summary

The Regulatory Affairs Specialist will reside within strategic business unit, Huber Specialty Minerals (HSM), at Huber Engineered Materials (HEM).

This person will be responsible for the following accountabilities, customer support and response, maintaining registrations (see below for specific registrations), managing safety data sheets and HAZCOM, overseeing product regulatory, and managing quality assurance components including but not limited to maintaining GMP, assisting in conducting internal audits, and supporting the quality team.

We are open to candidates who are fully remote so long as they are within reasonable distances to an airport for up to 20% travel.

Principal Duties & Responsibilities

• Develops and supervises global Regulatory Affairs support function to leverage Subject Matter Expertise (SME) for completion of Customer requests, Regulatory Responses, Product Dossier maintenance, and Document Control related to pharmaceutical, food, personal care, automotive, polymers, and industrial applications.
• Manages the regulatory response process to ensure timely and thorough completion of customer requests.
• Provides deliverables and support for Regulatory management system initiatives.
• Serve as primary contact for HSM hazard communication support and collaborate with HEM regulatory affairs for SDS / Labeling support.

Develop proficiency in the Wercs to serve as backup to HEM RA for SDS authoring activities.

• Proactively communicate proposed regulatory changes and emerging issues to the team and provide support to assess risk to business.
• Owner of QMS and cGMP regulatory requirements and educates the HSM team on QMS and cGMP regulatory expectations (ICH-Q7, ICH-Q1;

ICH-Q9; 21CFR111, 21CFR117, FSSC 22000, ISO-9001, USP Bulk excipient, etc.)

Registrations

• NSF registrations, currently 14 and 60.
• US-FDA facility and State registrations for Feed / Food / Pharmaceutical
• EU EDQM CEP registration and certificate
• FSSC 22000 registration and certification.
• US-FDA DMF

Requirements

• Master’s degree in chemistry, food science, food laws or similar with 2-3 years' experience OR bachelor’s degree with a minimum of five years’ work experience in regulatory affairs or the quality management systems for food / feed additives and / or specialty ingredients industry.
• Must be able to travel up to 20%.
• Previous Experience within Food and Pharmaceutical sectors.

Nice to have :

• Internal Auditor trained for ISO 9001, FSSC 22000, and ICH-Q7
• Proficiency in the Wercs SDS authoring tool

Skills we are looking for :

• Leader and Independent Driver - to take ownership of projects
• Strong communication skills - with a variety of leaders and customers
• Project Management

Total Rewards

J.M. Huber Corporation complies with all local / state regulations requiring salary range transparency.

Any offered salary is determined based on relevant factors such as an applicant's skills, performance, job responsibilities, prior relevant experience, certain degrees and certifications and market considerations.

U.S. Market-Based Salary Range

Regulatory Affairs Specialist

$81,700.00 - $108,100.00

In addition to base compensation, individuals may be eligible for an annual discretionary bonus and profit-sharing payout.

Huber also offers a comprehensive, competitive benefits package as detailed on the

Our employees are our strongest asset, and their safety, health, and well-being is our highest priority. We respect the individual by providing opportunities for professional and personal development.

Our Principles drive us to create an inclusive workplace where employees share core values, show dignity and respect toward others, and work hard to achieve their best performance.

J.M. Huber Corporation is an EEO / AAP employer. Pre-employment drug screening is required Atlanta

Nearest Major Market : Atlanta