Regulatory Affairs Manager
Fragrance Manufacturing Inc Allentown, PA
- Expired: over a month ago. Applications are no longer accepted.
We are FMI! A purpose-driven manufacturer of luxury personal care, home care, fragrance, and OTC products. Our growth has been unprecedented and we have an immediate need to find true people and process leaders.
FMI'spurposeis to "Inspire full potential." Ingrained in our DNA are strong core values which define who we are as a company and what we are unwaveringly looking for in employees.
- We are the customer's eyes.
- We are respectful, encouraging, and helpful.
- We are relentless and thoughtful to find the solution.
- We always do right- even when it's hard.
- We own it!
- We are "ALL IN".
About the team:
FMI takes a "white glove" approach to being a helpful resource to our customers. Our Regulatory and Compliance team is at the center of that, making sure FMI is providing accurate and informative guidance not only internally, but also to the companies we serve. When FMI says, "we are the customers' eyes", Regulatory and Compliance is at the helm, helping to ensure every formula that comes through our doors is safe and effective.
About the job:
We are looking for a dedicated and experienced Regulatory Affairs Manager to lead the Regulatory and Compliance team. Serving as the subject matter expert, you will play the leading role in guiding customers and fellow regulatory-affected operations to ensure full compliance with all local, state, and federal regulatory agencies and authorities including, but not limited to FDA, USDA, PA DOA, Organic, DEP, and EPA.
Serve as primary contact and subject matter expert (SME) for the following agencies/authorities:
- FDA, USDA, PA DOA, EPA, DEP, and Organic Certification
- Coordinate customer requests for information related to EU registrations
- Initiate and maintain all required registrations for the abovementioned agencies/authorities
- Initiate and maintain all OTC drug registrations
- Ensure successful inspections/audits of abovementioned agencies/authorities
- Serves as primary resource to FMI customers for all compliance matters of abovementioned agencies/authorities
- Review and validate all formula-related claims for FMI-manufactured products (including, but not limited to, SPF, VOC, BSE, Prop 65, Organic, Animal testing, Gluten Free, Vegan, etc.)
- Review product labels for content compliance
- Manage process for SDS for FMI-manufactured products
- Manage validation processes
- Bachelor's degree in Engineering or Science fields of study
- Demonstration of continuous technical training and education in the Regulatory Compliance arena
- Minimum 5 years' experience in a Regulatory Affairs or Quality position in an FDA-regulated manufacturing environment. Minimum 2 years' experience in a Regulatory position with similar responsibilities
- Experienced in FDA inspections and audits
- Demonstrated, strong understanding and knowledge of US OTC drug and cosmetic product regulations, as well as awareness or exposure to international cosmetic regulations
Fragrance Manufacturing Inc
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