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Sr. Regulatory Affairs Specialist

Integrated Resources, Inc

Edison, New Jersey

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Abbreviated New Drug Application, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Clinical Research, Code of Federal Regulations, Communication Skills, Cross-Functional, Detail Oriented, FDA (Food and Drug Administration), Federal Laws and Regulations, ICH Regulations, Information Technology & Information Systems, Pharmacy, Presentation/Verbal Skills, Product Development, Product Positioning, Project Tracking, Regulations, Regulatory Requirements, Regulatory Submissions, Rehabilitation Nursing, State Laws and Regulations, Writing Skills
LOCATION
Edison, New Jersey
POSTED
3 days ago
Sr. Regulatory Affairs SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.This is a Direct Hire role with the clientJob DescriptionJOB SUMMARYThis person will be a Regulatory liaison between product development and the regulatory agencies. This position will be responsible for regulatory submissions for new ANDAs and any changes being made to existing products. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products. This position will also interact with other departments and cross functional teams both in US and India.REPORTING RELATIONSHIPSDepending on the experience of the candidate, one labeling associate may report to this position.DUTIES & ESSENTIAL JOB FUNCTIONSRegulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests.Independently manage preparation (in paper or electronic formats (eCTD and SPL)), submission and monitoring progress of FDA review of ANDA'sCommunication with functional groups for coordination and preparation of data for submission to FDAManage all Regulatory, Federal and State License requirementsReview change controls for regulatory requirements and according to appropriate regulations and guidance's.Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc)Review labels as per FDA guidanceRegulatory support in drug listing.Perform other duties as assignedQualifications• BS or MS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy• 1 - 2 years' experience in pharmaceutical regulatory affairs (mandatory)• Attention to detail• Excellent oral and written communication skills• Knowledge of US drug regulatory requirements (mandatory)REQUIREDBS or MS in Sciences or PharmacyPREFERREDExperience with eCTD filingsRegulatory Affairs Certification (RAC)Job LocationDayton, NJ

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Integrated Resources, Inc