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1+ months

Regulatory Manager-Generic Pharma/ANDA experience required

Kelly Services
Springfield Gardens, NY 11413
**Kelly Services is seeking a Direct Hire Regulatory Manager with a client in Laurelton, NY.**


+ Conduct critical review of ANDA documentation to ensure final submission meet requirements of ANDA checklist recommended by FDA to avoid any refuse to file issues.

+ Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.

+ Organize and maintain submission components associated with a regulatory submission electronically.

+ Evaluate change controls and formulates strategies for correct filing categories

+ Works with colleagues in resolving regulatory issues and/or problems

+ Maintain current knowledge of regulations and other issues that affect products and industry.


Essential Duties and Responsibilities:


+ Conduct critical review on the submission documents for ANDA, amendment, supplement, annual report and responses to FDA deficiency letters

+ Review and approve change controls for CMC and labeling changes

+ Manage assigned projects and ensures that project deadlines and performance standards for these projects are established and met.

+ Preparation of documents and complete submissions to FDA in e-CTD format for ANDAs, Supplements and Amendments Review submission to FDA.

+ Review and approval of all Analytical Test Methods, specification forms and batch records

+ Conduct Training as required


Must have:


+ Minimum Bachelor s Degree in a Science related field.

+ Minimum 5 years in Regulatory Affairs Department of Pharmaceutical company

+ Generic Pharma experience

+ Prior experience managing a team of at least 2-3 employees

+ Ability to communicate effectively as part of a team

+ High level of accuracy and attention to detail while meeting deadlines

+ Excellent time management and multitasking skills in a fast paced environment.

+ Good problem solving and analytical skills

+ Strong computer skills: Word, Excel, Outlook, Adobe.


**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


**\#TJP2021_SPEC**


**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/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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-09 Expires: 2021-10-18

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Regulatory Manager-Generic Pharma/ANDA experience required

Kelly Services
Springfield Gardens, NY 11413

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