Pharmaceutical Consulting Generalist

The Company – Syner-G Pharma Consulting, LLC:

  • A 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

General Description:

This position is a 6-month contract position with possible extension for one of our pharmaceutical clients based in an area South of Boston. The Temporary Manager will develop and implement regulatory strategy for the firms’ programs. The Manager works closely with cross-functional teams and SME’s to support development and finalization of study-related regulatory documents. The Manager works on various routine regulatory submissions and assists in preparation with related submissions for meetings with various Health Authorities. The Manager will Ensure compliance with safety and periodic reporting requirements for IND’s.

Responsibilities and Duties:

  • Prepare regulatory submissions for INDs/CTAs original submissions and amendments, orphan designations, and pediatric investigation plans
  • Negotiate with regulatory agencies to resolve issues and coordinate preparation and submission of responses to questions from Health Agencies
  • Act as the primary regulatory liaison with medical writers, clinical, statistics, toxicology and DMPK teams as well as external CROs to provide regulatory support for trial initiation
  • Review technical and regulatory documents to ensure compliance with applicable regulatory guidelines, and requirements including SOPs

Required Skills and Experience:

  • Bachelor’s degree in biochemistry, chemistry, biology or related life/health sciences. Advanced degree preferred
  • Minimum 2-5 years of regulatory experience in a biotech/pharma company
  • Experience with Regulatory needs of clinical/preclinical development of biopharmaceuticals
  • Preparation of initial INDs, CTAs, DSURs and meeting briefing documents, NDA’s, or MAA or accelerated development programs
  • Must be knowledgeable in ICH, FDA and EMA guidelines
Job Category: Consultant
Job Type: Full Time

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