The Company – Syner-G Pharma Consulting, LLC: 

  • A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)
  • Adept in developing risk-based CMC strategies in accordance with cGMP for 21st Century initiatives and Quality by Design (QbD) principles
  • Distinguish ourselves by our passion for creativity and innovation
  • Offer flexible work environment allows for on-site, off-site and virtual-office scenarios
  • Clients include national and multinational pharmaceutical companies

The Candidate:

Syner-G Pharma Consulting is seeking a talented Senior Associate or Associate of Regulatory Operations with an AA/BS in Science, Chemistry, Biology, or Engineering.  The Senior Regulatory Affairs Associate role will ensure all relevant writing and editing requirements are met for regulatory submissions to the FDA and other regulatory agencies.  A successful candidate will work directly on the writing and reviewing of documents for regulatory section submissions; Format, edit, coordinate, and review regulatory documentation for inclusion in INDs, CTAs, and other worldwide submissions. The Dynamic Senior Associate will compile documentation for submissions to the FDA and to foreign regulatory agencies and maintain regulatory documentation.

Critical success factors:

  • Experience working in the Pharmaceutical industry
  • Associates or Bachelor’s degree in life sciences or a technical discipline; degree in Chemistry, Biology or equivalent preferred
  • Minimum of 2-3 years’ experience required in regulatory document authoring experience
  • Strong knowledge of MS Word, Excel, PowerPoint, and Outlook
  • Strong organizational, analytical, and problem-solving skills
  • Excellent written, verbal, and interpersonal skills
  • Strong attention to detail and ability to independently prioritize and multitask

Required Experience:   

  • S./B.S. in the life sciences with 2+ years of experience in CMC Documentation writing
  • Minimum of 2 years of experience in Pharmaceutical/Biotech industry required, including 1 years of experience in a Regulatory Affairs/Regulatory Operations capacity Review clinical and technical documentation for regulatory compliance
  • Coordinate with other departments to collect information for use in regulatory submissions
  • Knowledge of FDA guidance and industry standards
  • Experience compiling IND, NDA/BLA, and CTD submissions
  • Understanding of eCTD submission requirements
Job Category: Director
Job Type: Full Time

Apply for this position

Allowed Type(s): .pdf, .doc, .docx