Senior Regulatory Specialist Job at Sigan America, LLC.
Position Title: Senior Regulatory Affairs Specialist (EEO Category: Professionals (19-2031))
Reporting into Title: Global Regulatory Affairs Manager Regulatory Affairs
Department: Research & Development/Regulatory
Purpose/Summary:
This position is the day-to-day liaison between customers and our R&D team to support the development of compliant and safe cosmetic/OTC formulations. Responsible for managing, completing, communicating, and prioritizing all our customers’ regulatory projects meeting expected timelines. Follows, interprets, and reports on developing Global and Regional Personal Care/Cosmetic Regulations, including but not limited to: US FDA, IFRA, Health Canada, EU Cosmetic Regulation. Keeps R&D Team updated of changing regulations and develop formulation guidelines. Creates plan options to smoothly phase through necessary changes. Maintain Company compliance with FDA, etc. as needed.
Direct Reports: None.
Knowledge-Skills-Abilities MUST HAVE experience with Cosmetics/OTC Regulatory Affairs
Education:
- BA or BS Degree in Science related field
- Or equivalent progressive work experience
Experience:
- Possesses Regulatory Compliance experience with 2-4 years in equivalent position.
- Requires proficient working knowledge of EU Cosmetic Regulation, PCPC, INCI names, Cosmetic Labeling Requirements.
- Understand NGO requirements, such as the Non-GMO Project.
- Understands the importance of new information for both current and future problem-solving and decision-making, with regards to regulation and compliance.
- Formulates conclusions and solutions, using logic, reasoning, and analysis of gathered data, information, and relatable events, concerning regulatory compliance.
- Maintains regularly updated physical and electronic files that are retrievable, accurate, and audit worthy.
- Recognizes urgency and reacts timely with necessary information or actions.
- Prioritizes actions and activities to meet expectations, including changing expectations.
- Adjusts actions in response to situation and available information.
Technology/Software (years):
- Possess strong computer literacy skills in MS Excel, Word, Outlook and Powerpoint.
- Utilizes a database and other digital files to create reports and dossiers.
Requirements:
- Must have good communication skills (both verbal and written)
- Must work effectively as a team member in all situations.
- Must work well under pressure.
- Must exhibit strong leadership skills in a fast-paced plant operations environment
Job Type: Full-time
Pay: $65,000.00 - $80,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Ottawa, IL 61350: Reliably commute or planning to relocate before starting work (Required)
Experience:
- FDA regulations: 1 year (Preferred)
Work Location: One location
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