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29 days old

Associate Director of Regulatory Affairs

Kelly Services
Mahwah, NJ 07430
**Associate Director Regulatory Affairs**


**Job Description:**

The focus of this role is to provide regulatory due diligence and oversight on in-house and outsourced APIs. It includes being the interface between Regulatory authorities for all matters related to APIs and Drug Master Files (DMFs). This role is responsible for developing the API regulatory filing strategy and maintenance of all DMFs, staying current on all applicable regulations and laws, and providing guidance to the API team on US FDA filing requirements. This role also aids the regulatory team in satisfying the regulatory requirements/queries of external API customers, as well as working with Logistics and FDA on API import issues.


**Job Responsibilities**


+ Develop regulatory filing strategies, preparation, review, and submission for New US FDA and Canadian DMF applications for in-house manufactured APIs.

+ External Interfaces Internal Interfaces

+ Regulatory Agency ( FDA, HC etc.) Global Regulatory Teams QA RA (US)

+ Work to minimize regulatory issues and help to prevent unnecessary regulatory delays.

+ Provides day-to-day support and expertise with respect to CMC and other regulatory requirements related to DMFs.

+ Provide understanding of FDA current requirements for manufacturing processes, Impurities, Analytical methods, Validation, specifications, storage and stability, etc.

+ Provide scientific input in API Development and Manufacturing process.

+ Assemble and maintain various company in-house databases, such DMF lists and tracking systems for FDA submissions

+ Interacts with Regulatory Agency representatives and partners/clients to facilitate approval of regulatory submissions (FDA/HC)


**Knowledge, Skills and Abilities**

Education M.S. Organic Chemistry preferred

Experience 5-7 years of Regulatory experience

Extensive knowledge of USP, ICH guidelines and organic chemistry


\#P1


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-05 Expires: 2022-10-10

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Associate Director of Regulatory Affairs

Kelly Services
Mahwah, NJ 07430

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