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Regulatory CMC Specialist
Ref No.: 18-00046
Location: Parsippany, New Jersey
Position Type:Direct Placement
Start Date: 03/01/2018
Pay Rate : $ 73,000.00 - 83,000.00 /Year
Regulatory CMC Specialist

Location: Morris County, NJ
Salary: TBDK+ Bonus
**This is a Perm/Salary Job. NO Third Parties, Sponsorship is Not available.

Provide Regulatory Support for Current Products and Development Projects
  • Provide CMC-related Regulatory support and input.
  • Deliver projects and other initiatives to progress current product portfolio by providing CMC-related direction and support to stakeholders.
  • Collect and collate CMC data required for registration submissions.
  • Prepare CMC-related submission packages for the appropriate Regulatory Agency.
  • Correspond with the appropriate Federal or State Agency regarding registration submissions.
  • Review product labeling and supporting materials.
  • Review and assess relevant change controls (via Trackwise); maintain product compliance summaries (PCS), product registration records (via GRAIS system) and ensure all necessary product-support documentation is accurate and prepared in accordance with agreed timings.

Implement New Regulations and Guidances
  • Assess impact of new CMC-related regulations and guidance documents.
  • Work with key internal stakeholders (e.g, R&D) to implement requirements within specified timelines.
  • Keep current with all relevant guidance documents and regulations while also monitoring any changes that occur which may impact currently marketed products.
  • Assess and communicate all CMC-related requirements to stakeholders in order to maintain compliance without delay to business due to Regulatory issues.
  • Work with Project Managers to adjust and monitor CMC-related timelines to support the business.

Support Infrastructure and Systems Integration
  • Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated our client's products within North America (US & Canada) and the Caribbean.
  • Contribute towards infrastructure projects (processes, procedures, systems etc.) and provide CMC-related perspective.
  • Deliver project- and brand-specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.

My Client:
  • Vacation. We offer 4 weeks' vacation, 9 core Holidays and 4 floating days.
  • 16 weeks paid Maternity leave.
  • Competitive base salaries and bonuses.
  • Tuition reimbursement.