Description

The primary role is to help ensure regulatory compliance and to support the maintenance of the Company's marketed products throughout the product lifecycle. This support includes performing regulatory activities necessary to maintain and to grow the business.

With moderate supervision by the Regulatory Manager, this position is responsible to perform regulatory activities to support product development and registration projects, including the launch of new and existing skin care cosmetic and drug products and other projects as assigned. The Senior Specialist will research product ingredients, review formulations, approve label ingredient statements, review and approve artwork to help gain market authorizations. S/he will also submit notifications and reports to federal and state governments to help assure ongoing compliance with regulatory requirements, and will be coordinating the document compilation for the registrations in the countries outside of the USA, by the Distributors. S/he may also draft procedures for the Regulatory processes/instructions.

Skill/Experience/Education

Mandatory

Education and Experience:

• University degree required; a degree in Life sciences or Regulatory Affairs Certification is preferred (e.g., chemistry, pharmacy, biology) but not required

• 5+ years experience in North America regulatory affairs, with focus on cosmetics, cosmetic-drugs, NHPs and/or DIN drugs, sunscreens

Desired

• Detail oriented. Good communication skills (interpersonal, writing and oral)

• Project management and organizational skills

• Good knowledge of Google tools for word processing, spreadsheets and presentations

• Strong interpersonal and relationship-building skills

• Sound analytical thinking; ability to analyze technical data, to interpret and recognize implication of results and to recommend next steps

• Ability to successfully juggle multiple competing priorities while maintaining attention to detail and adherence to priorities

• We will prefer hybrid, working from our Piscataway office 3 days/week if possible, but will also consider fully remote.

Job Type: Contract

Salary: $40.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 6 years (Required)
• North America regulatory affairs: 6 years (Required)
• cosmetics, cosmetic-drugs: 6 years (Required)
• NHPs and/or DIN drugs,: 6 years (Required)
• sunscreens: 6 years (Required)

Work Location: Remote

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