Sr Scientist, Regulatory Affairs

2 weeks ago

Clark, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer an opportunity to work as a Sr Scientist, Regulatory Affairs located in Clark, NJ.


Duration: 9-12month contract with the potential to extend or go perm.

Schedule: Monday-Friday, 8A-5P

Location: Clark, NJ (ideal if candidate is willing to travel hybrid between Clark NJ and NYC)

Compensation: $50-60/hr

Purpose of the Role:

  1. Administer regulatory affairs over the product lifecycle from pre-market concept, product development, registration
  2. Actively support regional regulatory affairs teams and documentation requirements.
  3. Support risk management, regulatory intelligence and continual improvement projects.


Responsibilities:

Regulatory Compliance:

  1. Review formulations to ensure compliance of finish products with global regulatory standards
  2. Provide advice to labs and product development teams and give guidance on potential regulatory compliance issues
  3. Respond to inquiries regarding ingredients, formulations, regulatory issues and associated requirements.
  4. Prepare and review of regulatory compliance documents for product registration
  5. Register products according to regulatory requirements/ Support regulatory reporting and registration requirements
  6. Regularly update registration database and advise key stakeholders of the progress of registrations.
  7. Keep abreast of regulatory changes in our markets, assessing and communicating impact to the Regulatory Affairs team and other internal stakeholders / Monitor new regulations, evaluate impact to the business and lead on next steps
  8. Support Risk identification, reduction, mitigation and escalation processes
  9. Manage regional projects and be able to collaborate with countries and to set up priorities
  10. Accurately compile and procure notarised documentation, such as Certificates of Free Sale

Others:

  1. Support and maintain Regulatory procedures/position statements.
  2. Support other activities (artwork, post-market advertising compliance and vigilance activities)
  3. Support Regulatory Department Improvement Projects


Qualifications:

Technical Requirements:

  1. Degree in Science (Pharmaceutical Science, Pharmacy, Health Science, Food Science, Nutrition, Chemistry – highly regarded)
  2. Application and understanding of MoCRa
  3. Application and understanding of FDA regulations

Key Experience, Knowledge & Skills Required:

  1. 3-5 years’ experience in regulatory and/or product safety in cosmetics, personal care, chemical or dietary supplement industries
  2. Demonstrated experience interpreting FDA regulations for drug products and for cosmetics MoCRa,
  3. Developed experience in regulatory artwork copy briefing and proofing.
  4. Developed communication and presentation skills.
  5. Ability to navigate ambiguity, manage stakeholders in fast paced environments.
  6. Critical thinking and keen attention to detail.
  7. Strong time management and organisational skills.
  8. The ability to be onsite, in the office as this is an essential function of the position (required)
  9. Authorization to work in the United States on a full-time, permanent, ongoing basis without the need for legal sponsorship now or in the future (required)


P#1

Send resumes to Jacqueline.Sayoc@KellyScientific.com

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