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Key Responsibilities

  • Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation
  • Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders
  • Assist with ongoing GXP systems transition, related to change control and regulatory dossiers
  • Ad hoc RACMC support to line manager
  • Assist with post-approval and investigational life cycle management as needed, including but not limited to post-approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
  • The outlined tasks may be subject to change as the workload of the business requires

Desired Abilities

  • Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents
  • Good writing skills for technical writing
  • Detail-oriented and highly organized
  • Good verbal communication skills for leading meetings and remote interactions
  • Work well in a team setting on a fast-paced business-critical project
  • Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company

Education and Experience

  • Scientific and educational background (BSc or MSc) to understand pharmaceutical drug development concepts, and regulatory concepts and create documentation based on these concepts
  • Comprehensive understanding of regulations and guidelines to enhance the probability of regulatory success and regulatory compliance
  • Excellent project management skills

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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