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Regulatory Affairs Specialist III

  • Full-Time
  • Bridgewater, NJ
  • Katalyst Healthcares & Life Sciences
  • Posted 2 years ago – Accepting applications
Job Description
Roles and Responsibilities:
  • Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards are properly and timely implemented
  • Provide support to Regulatory CMC managers in developing strategy for development projects, including assigned projects and back-up projects
  • Participate in CMC project team meetings and provide Regulatory CMC support as needed, including update to the teams on follow-up actions, information request, risk assessment and mitigation in support of clinical trial application and marketing application.
  • Review CMC section of submission dossiers for clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for development compounds
  • Support response to CMC queries from worldwide Health Authorities, including acquiring the requested information, creating/updating response documents, coordinating review and finalizing the response
  • Review CMC supporting documents (GMP certificates, Manufacturing/Import Authorization, CoA, QP declarations, MBR) and request these documents from the appropriate associates
  • Accountable to manage the database of GMP certificates & Manufacturing/Import Authorization in Veeva Vault to ensure the documents are up to date for the covered manufacturing sites in the database
  • Analyze CMC queries from regulatory agencies to look for trending deficiency for improvement of CMC section to support clinical studies and marketing applications
  • Consult with SMD management and RA CMC managers for issues. Drive to ensure timely and appropriate resolution of the issues
  • Experience with the dynamic regulatory landscape, especially in CMC and quality aspects
  • Expertise in ICH, EMA and FDA guidelines
  • Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide
  • A good understanding of CMC requirements for clinical trial applications and marketing applications for small molecule
  • Managing expectations on deliverables to meet tight timelines. Handling timeline pressure
  • Cultivating business relationships with GRA, CMC teams, RegOps, CDDC, GRA regions and local affiliates
  • Ability to quickly analyze RCMC issues to troubleshoot for resolution for business continuity
  • Experience in development of Regulatory CMC strategy in support of submissions of clinical trial applications and marketing applications
  • A good understanding of Regulatory CMC requirements for clinical trial applications and marketing applications
  • Knowledge of worldwide CMC requirements including US, EU, China, Japan, APAC, LATAM and EMEA
  • Expertise in quality guidelines of ICH, FDA and EMA
  • Demonstrated ability to multi-task and to work in a fast-paced global environment
  • Ability to work under pressure to meet short timelines
  • Ability to work with shifting priorities to meet project deliverables
  • Good verbal and written communication skills
  • Strong interpersonal and collaboration skills
  • Self-motivated professional
Education and Experience:
  • Bachelor's degree in chemistry, pharmacy, biology or scientific discipline
  • Minimum three years' experience in the pharmaceutical industry
  • Knowledge of Regulatory CMC requirements for clinical trial applications and marketing applications
  • Expertise in quality guidelines of ICH, FDA and EMA
  • A good understanding of the drug development process and pharmaceutical development
  • Working knowledge of regulatory CMC dossiers for clinical trial applications and marketing applications
  • Proficient in MS Word, Excel, PowerPoint and MS Project
  • Effective communication skills
  • Strong interpersonal skills to be effective in the global team environment
  • Fluent with the English language. Knowledge of French and/or other EU languages is desirable
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