Della Infotech
Regulatory Affairs Associate
Della Infotech, Piscataway, New Jersey, us, 08854
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 also submit notifications and reports to federal and state governments to help assure ongoing compliance with regulatory requirements, and will be supporting the Distributors registrations in the region. S/he may also draft procedures.
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.
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 also submit notifications and reports to federal and state governments to help assure ongoing compliance with regulatory requirements, and will be supporting the Distributors registrations in the region. S/he may also draft procedures.
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.