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20 days old

Permanent position- Regulatory Senior R&D Technician- Edison, NJ

Kelly Services
Edison, NJ 08899
**Regulatory Senior R&D Technician**



**Edison, NJ 08837**



**Permanent position**





**Required Skills:**




+ Experience working in R&D or Regulatory Affairs where OTC products are developed.

+ Experience working with formulation and ingredients, knowledge of ingredients used in cosmetics. Knowledge of FDA regulations for drugs and cosmetics





**SUMMARY:**



The Regulatory Sr. Technician works directly with our R&D Product Development Chemists, Scale-Up Engineers and our Third-Party Testing Laboratories to effectively manage the activities from customer product formulation approval to fully tested, compliant and approved OTC commercial product for consumer sale.





**DUTIES AND RESPONSIBILITIES** :




1. Review approved OTC and non-OTC customer formulas and manage the collection of testing samples, distribution to approved testing labs, and initiation and tracking of testing from inception to completion.

2. Work with R&D chemists to analyze testing data, and generate customer summaries and results, including Product Dossiers, Drug Stability reports, RIPT and micro challenge reports, as examples.

3. Review and confirm validation requirements and compliancy of approved OTC formulas, using internal Regulatory and Engineering teams support.

4. Interface with customers and sales personnel to provide testing quotations as requested by them, upon final product formulation approval.

5. Manage and maintain all 3rd party testing for OTC and non-OTC products conducted on behalf of R&D and customers.

6. Participate in customer regulatory/quality audits as needed.





**QUALIFICATIONS:**




+ Bachelors degree with Major in Chemistry, Chemical Engineering or Biology

+ Minimum of 2 years of experience working in R&D or Regulatory Affairs where OTC products are developed.

+ Interest and/or first-hand knowledge of FDA regulations for drugs and cosmetics, and other global regulatory bodies.

+ Experience working with formulation and ingredients, knowledge of ingredients used in cosmetics

+ Familiar with Personal Care Products Council organization and cosmetic industry

+ Strong organizational, problem-solving, attention to detail, and analytical skills

+ Proven ability to handle multiple projects and meet deadlines

+ Strong interpersonal skills






**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-07-17 Expires: 2020-08-27

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Permanent position- Regulatory Senior R&D Technician- Edison, NJ

Kelly Services
Edison, NJ 08899

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