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Regulatory Affairs Specialist

5+ years
$81,700.00 - $106,100.00
10 July 31, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Affairs Specialist

Date: July 16, 2024
Location: Atlanta, GA, US
Company: J.M. Huber Corporation
Portfolio Business: Huber Engineered Materials

About Us:
J.M. Huber Corporation, a leading privately held, family-owned company, has been a trusted name since 1883. With a diverse portfolio including specialty and commodity chemicals, hydrocolloid solutions, engineered wood products, and natural resources, we cater to a wide range of industries globally. With approximately $3 billion in sales and 4,000 employees in over 20 countries, we pride ourselves on our longstanding tradition of excellence and innovation.

Position Summary:
We are seeking a Regulatory Affairs Specialist for our Huber Specialty Minerals (HSM) business unit within Huber Engineered Materials (HEM). This role involves managing regulatory compliance, safety data sheets, hazard communication, and quality assurance processes. The position can be remote, provided candidates are within reasonable distance to an airport for up to 20% travel.

Principal Duties & Responsibilities:

  • Oversee global regulatory affairs support, leveraging Subject Matter Expertise (SME) for customer requests, regulatory responses, product dossier maintenance, and document control.
  • Manage the regulatory response process to ensure timely and comprehensive completion of customer inquiries.
  • Support Regulatory Management System initiatives and act as the primary contact for HSM hazard communication, collaborating with HEM for SDS and labeling support.
  • Stay informed of proposed regulatory changes and emerging issues, assessing their impact on the business.
  • Lead QMS and cGMP regulatory requirements, educating the HSM team on relevant standards such as ICH-Q7, ICH-Q1, ICH-Q9, 21CFR111, 21CFR117, FSSC 22000, ISO-9001, USP Bulk excipient, etc.

Registrations:

  • NSF registrations (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 a related field with 2-3 years of experience, OR Bachelor’s degree with a minimum of five years in regulatory affairs or quality management systems for food/feed additives and/or specialty ingredients.
  • Ability to travel up to 20%.
  • Experience within Food and Pharmaceutical sectors.

Preferred Qualifications:

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

Skills We Seek:

  • Leadership and Independence in managing projects
  • Strong Communication Skills with leaders and customers
  • Project Management capabilities

Total Rewards:
J.M. Huber Corporation offers a competitive salary range for this position between $81,700.00 and $106,100.00, based on relevant factors such as skills, performance, job responsibilities, and market considerations. In addition to base compensation, there may be opportunities for an annual discretionary bonus and profit-sharing payout. Our comprehensive benefits package is detailed on the Huber Benefits Hub.

Commitment to Diversity and Inclusion:
We are committed to creating an inclusive workplace where all employees are respected and valued. J.M. Huber Corporation is an EEO/AAP employer, and we provide equal employment opportunities without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status. Pre-employment drug screening is required.

Connect with Us:
If you are ready to contribute to a dynamic team and grow your career with J.M. Huber Corporation, apply today!