Director Regulatory Affairs

  •  

White Plains, NY

Industry: Biotech/Pharma

  •  

11 - 15 years

Posted 358 days ago

  by    Nancy Christie

Regulatory Affairs Director – Pharmaceutical

Our client is a global leader in pharmaceutical solutions providing prescription products across multiple call points. They are seeking to hire a Regulatory Affairs Director responsible for managing the creation and review of filings for new generic drugs and monitoring the activities and submissions of new products. The role also manages the labeling process including the creation and implementation of labeling and the regulatory requirements associated ensuring compliance.

Responsibilities:

  • Monitor the creation, review, evaluation and submission of new drug filings/applications and reports in compliance of FDA submissions and drug filing regulations (U.S. & International)
  • Oversee Chemistry team; ensure projects are completed within deadline and respond to deficiencies
  • Manage post-marketing activities; Supplements submission, reporting, drug listing, etc.
  • Review product development reports and provide regulatory guidance
  • Maintain comprehensive electronic lists for deficiencies
  • Ensure prototype formulation compliance with Inactive Ingredient Database and provide CMC requirements guidance
  • Liaison for customs release inquiries and detained shipment releases
  • Review/update Standard Operating Procedures for CMC, labeling and filing
  • Create and review FDA submission documentation of SPL conversion of labeling
  • Monitor labeling filings, prepare new submissions and provide strategies
  • Manage label creation process/procedures; review and implement all labeling
  • Ensure company compliance and fulfillment of regulatory requirements in relation to labeling
  • Collaborate with regulatory agencies/groups for development of labeling

Requirements:

  • Bachelor’s Degree
  • Master’s Degreepreferred
  • Min. 10+ years’ experience in Pharmaceutical Regulatory CMC and Labeling
  • Previous experience within generic pharmaceutical industry
  • Knowledge/Understanding of regulatory guidance, CFR, USP and ICH
  • Previous RA labeling experience strongly preferred
  • Knowledge/Understanding of drug development and post approval maintenance
  • Knowledge/Understanding of Chemistry batch records
  • Ability to prioritize & multi-task, ability to work collaboratively
  • Strong communication & project management skills
  • Advanced computers skills required

Offering:

  • Base Salary $120,000 - $150,000 (based on experience)
  • Bonus Potential
  • Full Benefits Package: matching 401K
$144K - $180K
$120K - $150K base, relocation package bonus