Job Description :
Hi,
Hope you are doing well.
Please find the job description below and let me know your interest.
Position: Regulatory Affairs Manager
Location: co
Duration: 6+ months
Mode of Interview: Phone and F2F
Job Description:
Minimum of 8 years’ experience in Pharmaceutical Industry preferably in Quality Assurance, Quality Control Laboratory, or Regulatory Affairs at a pharmaceutical manufacturer.
Manages activities for the assembly of documentation required for drug master file submissions.
Responsible submission of new Drug Master Files (DMF)
Work with corporate Regulatory Affairs for preparation of appropriate portions of drug product submissions for materials manufactured at Cody Laboratories.
Actively engages in continuous improvement of cGMP regulatory compliance, standards, policies and procedures.
Interfaces with regulatory agencies through written correspondence, face to face meetings etc. Interacts/negotiates with FDA regarding issues on submissions.
Provides regulatory input and guidance for new product development teams. Participates in the creation of regulatory strategy for new products.
Reviews change control documentation to assess impact upon regulatory filings for affected materials. Coordinates the review of appropriate Laboratories change controls by corporate regulatory affairs.
Reviews deviations and investigations to assess impact upon regulatory filings.
Represents regulatory affairs as a member our clients Labs Material Review Board. Provides input to discussions concerning quality issues.
Prepares and submits FDA Establishment Registrations to the FDA.
Keeps abreast of changes in regulatory requirements for drug master files and drug products.
Education/Experience:
Bachelor’s degree (B.A. or B.S in Chemistry, Pharmacy, or Biological Science from four-year college or university