Director of Regulatory Affairs Job at Della Infotech Inc
Essential Duties/Responsibilities:
Role Summary:
The primary role of the Regulatory Affairs Associate is to help ensure regulatory compliance and to support the maintenance of the Company's marketed products throughout the product lifecycle in the Americas region. 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 Associate will research product ingredients, review formulations, approve label ingredient statements, review and approve artwork to ensure product and ingredient claims are compliant with applicable regulations. S/he will support the Regulatory Operations team to assemble the product files for the country registrations in Americas region and reporting/listing to federal and state governments to help assure ongoing compliance with regulatory requirements. S/he will also follow up the Regulatory landscape (Sunscreens, ingredients of concern, etc) for the SkinCare/Skin Health products in the Americas region and may also draft procedures accordingly.
Minimum Education Required: 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-OTC drugs, NHPs and/or DIN drugs, sunscreens
- Understanding of Global Regulatory Landscape
- Detail oriented. Good communication skills (interpersonal, writing and oral).
- Project management and organizational skills.
- Good knowledge of Google tools for documents, 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.
Job Type: Contract
Salary: $38.00 - $39.00 per hour
Benefits:
- Dental insurance
- Health insurance
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Experience:
- North America regulatory affairs: 5 years (Required)
- FDA regulations: 4 years (Required)
- cosmetics: 5 years (Required)
- cosmetic-OTC drugs: 5 years (Required)
- DIN drugs: 5 years (Required)
- Sunscreen: 5 years (Required)
- Healthcare: 5 years (Required)
Work Location: Remote
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