Sr. Regulatory Affairs Specialist

Ames, IA 50014

Post Date: 04/02/2018 Job ID: 559.17SS Industry: Laboratory - Industrial Chemicals

Sr. Regulatory Affairs Specialist

The Sr. Regulatory Affairs Specialist will be responsible for writing, reviewing and submitting submissions.  Incumbent will be the primary FDA contact.  Experience in obtaining, maintaining and managing site accreditation with foreign Health Authorities (Korean FDA, Indian FDA and PDMA (Japan).

*Write, review, compile and submit new Drug Master Files /CEP Common Technical Documents and their submission with the relevant Regulatory authorities

*Review, compile and submit amendments, updates and updates to existing DMFs for filing with the relevant Regulatory authorities

*Manage document and maintain all company regulatory filings with Health Authorities

*Serve as primary site liaison with Health Authorities concerning regulatory filings (i.E. Issue LOA's, responding to deficiency letters, requests for additional information )

*Serve as a liaison with new and existing customers concerning regulatory filings (i.E. Issuing CEPs, preparation and submission of Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, communicate changes and proposed changes, coordinate responses to customer inquiries)

*Obtain, maintain and manage site accreditation with foreign Health Authorities as Korean FDA, Indian FDA and PDMA (Japan)

*Provide guidance and in-put to project teams on regulatory requirements and guide compilation of DMFs/Registration Dossiers

*Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact

*Provide regulatory council on new and existing raw material, in-process and product specification and test methods

*Review of data received from R&D, manufacturing, analytical, supply chain and quality assurance departments

**If you'd like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at 815.756.1221 / [Click Here To Join].

JO:  559.17SS

#LI-SS2

Requirements:

*Bachelor's degree in a life science discipline, chemistry preferred

*M. Pharm. Or M.Sc. /Ph.D. In Chemistry

*5-10 years of relevant experience in regulatory affairs

*Coordination and problem solving skills

*Interpersonal and people skills

*Planning, organizing and project management skills

*Employee training and development skills

*Oral and written communication skills

**If you'd like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at 815.756.1221 / [Click Here To Join].

JO:  559.17SS

#LI-SS2

STEVE SAPITA
Technical Recruiter

SPECIALTIES:  All Industrial Research & Development Laboratory related positions including: Formulation Chemist; Synthetic Chemist; R & D Leadership; Analytical Chemistry; Technical Service; Regulatory; Project Mangers; Process Chemistry; Environmental and Health; Quality Positions; Material Scientist. 

EXPERIENCE:  My area of specialty includes: Coatings, Adhesives, Sealants, Specialty Chemicals, Building Materials, Polymers, Petrochemical, Agrochemical; Surface Cleaners; Ink; Surfactants; Resins. 

The levels of candidates that I place include Chemists; Sr Chemists; Innovation; Directors; Quality Professionals; Technical Service Professionals; Production Supervisors; EHS Specialists; Scientist; Regulatory Professionals; and Laboratory Support Personnel.  

I’M IN THIS BUSINESS BECAUSE:  There’s no better feeling than helping someone realize their potential by assisting them in advancing their career.  I love making that connection!  My goal is to consistently build long lasting relationships with both my clients and my applicants.

CLIENTS CAN COUNT ON ME BECAUSE:  I pride myself on the quality of my work and I truly CARE about their needs.  The better I know them, the better my understanding is as to who would fit their needs.


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