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Regulatory Affairs Manager

Fragrance Manufacturing Inc Allentown, PA

  • Expired: over a month ago. Applications are no longer accepted.
Job Description
Who are we?

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.

To be successful in this role, you will have excellent interpersonal skills with a can-do mindset, be organized and detail-oriented, are comfortable working in a fast-paced environment, and be able to analyze and interpret complex regulations and create a clear and concise explanation for customers when needed.

Responsibilities:

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

Requirements:

  • 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
Affirmative Action/EEO statement:
FMI is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. You may view our Equal Employment Opportunity notice upon request. FMI is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us through the job board.

Fragrance Manufacturing Inc

Address

Allentown, PA
USA

Industry

Government

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