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North American Regulatory Lead

hace 2 semanas

Lima Metropolitana, Perú Thermo Fisher Scientific A tiempo completo

Job Description

The Regulatory Affairs Specialist will provide expert advice and support to ensure timely and effective product registration in North America.

Main Responsibilities
  1. Preparation of regulatory documentation and submissions, ensuring compliance with local, regional, and ICH requirements.
  2. Coordination of client deliverables, working closely with internal and external stakeholders to manage long-range planning and multiple projects.
  3. Exercise independent judgment to assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables.
  4. Stay up-to-date with global, regional, and national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
New Challenges and Opportunities
  1. Oversight of submissions to Regulatory Authorities and/or EC/local submissions, including North America IRB submissions.
  2. Management of country-specific local applications, overseeing the entire process from preparation to approval.
  3. Collection of regulatory requirements and coordination of country-specific local applications, relying on RegView entries and follow-ups with CASs.
  4. Standardization of RAL procedures applicable to EC and RA submissions.
  5. Development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs and Canadian ECs submissions.

Work Environment

  1. Office setting with exposure to standard office equipment.
  2. Infrequent travel to site locations with occasional business trips, domestically and internationally.

Requirements and Essential Skills

  1. Bachelor's degree or equivalent and relevant formal academic/vocational qualification. Relevant work experience comparable to 2+ years.
  2. Excellent written and verbal English language skills.
  3. Attention to detail, quality, and editorial/proofreading skills.
  4. Effective teamwork and interpersonal skills.