Regulatory Affairs Manager
Biogen
Bogota,Colombia
hace 6 días

Summary

  • Support Regulatory Strategies for new products at local and Global level; Constant and aligned communication with Global Regulatory team;
  • Support and coordinate all post-registration changes for registered products;
  • In charge of product renewals in due date
  • Responsible for request and organizations of all local regulatory authorities GMP Inspections in international manufacturing sites and related renewals based on local sanitary dispositions in Colombia;
  • Job Description

  • Request and organize all RA’s Meetings : pre-filing, Technical queries discussion, New Medicines and Inspection clarifications and so forth;
  • Ensure Products labelling update;
  • Assure Regulatory governance (spreadsheets, Regulatory SOP s, documentation filling);
  • Regulatory Intelligence : maintain all Board of directors updated with Regulatory environment;
  • Grant a cross functional work and maintain regulatory updates / communication with all Areas;
  • Excellent Transit with Health Authorities and Pharma Chambers;
  • Qualifications

  • Deliver results :
  • Organization and detailed orientation;
  • Focus on timelines;
  • Work Cross Functionally;
  • Sense of priority
  • Good transit with Health Authorities at local and Federal level
  • Good communication skills
  • Initiative and take fast decisions
  • Constant Interest in acquiring new knowledge
  • Discretion to handle a sensitive subject such as product safety data;
  • Self-Control to work under pressure
  • Deliver results :
  • Organization and detailed orientation;
  • Focus on timelines;
  • Work Cross Functionally;
  • Sense of priority
  • Good transit with Health Authorities at local and Federal level
  • Good communication skills
  • Initiative and take fast decisions
  • Constant Interest in acquiring new knowledge
  • Discretion to handle a sensitive subject such as product safety data;
  • Self-Control to work under pressure
  • Availability to travel
  • Experience in dealing with authorities
  • Hands on (suit to work in a startup)
  • Education

    Education : Knowledge & Skills

  • Graduation in Chemistry, Pharmacy, or Biochemistry;
  • Previous experience is required more than 5 years;
  • Experience in regional regulations (Colombia and Colombia)
  • Fluency in English;
  • Good skills in informatics programs : Excel, Word, Power Point, etc;
  • Mid-Senior Level

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