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Regulatory Scientist/Senior Regulatory Sceintist, Chemistry, Manufactirung & Controls

Cambridge (MA), USA

Responsibilities:

  • Write, review and assemble high quality regulatory submissions, such as Quality Modules of Marketing Authorization Applications (MAA/NDA/BLA), Investigational New Drug (IND/IMPD), Variations, pre-IND briefing documents, etc.;
  • Participate as team member, leader, or advisor in a number of the company’s projects, in an international environment
  • Serve as in-house regulatory expert for internal and external projects
  • Participate to the definition and implementation of CMC regulatory strategies for development and registration of innovative drugs;
  • Provide advice on operational and technical CMC subjects (Manufacturing, analytical development, validation, specification setting, stability, etc.);
  • Provide support for the preparation of Agency meetings (EU and US);
  • Monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members;
  • Ensure compliance with regulations and applicable guidelines;
  • Stay up to date with CMC EU and US trends and requirements.


Experience:

  • At least 2 years proven professional CMC (small molecules and/or biologicals) experience;
  • Additional 2 years of regulatory experience is preferred;
  • Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
  • Experience with Project Management is a plus;
  • Direct interactions with the Health Authorities is a plus;
  • Experience in a consulting environment is a plus.


Personal attributes and skills:

  • Strong problem solving skills
  • High motivation and flexibility;
  • Client- and business-oriented;
  • Proven ability to meet deadlines;
  • Ability to work in a multicultural environment;
  • Proactive and enthusiastic approach to collaboration with internal and client teams;
  • Strong written and verbal communication, presentation, and facilitation skills;
  • Excellent working knowledge of MS Office (Word, Excel, PowerPoint) is essential.