Regulatory Affairs Specialist

Há 2 dias

Rio de Janeiro, Rio de Janeiro, Brasil beBeeRegulatory Tempo inteiro US$85.000 - US$110.000
Job Overview

This is an exciting opportunity to join our Regulatory Affairs team as a highly motivated and experienced professional. As a key member of our team, you will be responsible for maintaining all Marketing Authorizations valid in Brazil, registering new products while monitoring and updating on Brazilian health regulations daily.

Main Responsibilities and Opportunities
  • Regulatory Affairs:
    • Support in regulatory submissions for new product registration, register renewal, post-changes, Product Changes History (HMP), Plasma Master File (PMF) updates for submission and product discontinuation (if needed).
    • Support in all processes related to communication with regulatory organizations such as Anvisa, CRF, Visa, Minister of Health.
    • Join meetings with main organizations, such as Sindusfarma, Anvisa, class entities (if needed), etc.
    • Monitor publications of health legislations and public consultation, acting as an active member of those group discussions.
    • Disclose new legislations and changes to current legislation to interested areas.
    • Packaging Material Review: Support the E2E Packaging Material review process based on local legislation and according to guidelines. Maintain database updated.
    • Support to maintain performance management and routine activities on target; KPI's management.
    • Interact with International Drug and Regulatory Affairs Team (IDRA), based in Vienna.
  • Tenders:
    • Maintain all technical documentation updated to support a Tender Process. Support and active participation in Tender Processes.
    • Final Product Import Process: Perform assessment in all import processes, to private or non-private market related to temperature excursions, raise batch release reports, risk assessment for medicines that have quality deviation. Dataloggers assessment.
  • Quality Assurance:
    • Complaints and Recalls: Handling of all quality deviations, according to Brazilian legislation and internal procedures.
  • Marketing Materials:
    • Revision of the technical content of the Marketing material prepared by the sales force.
  • Pharmacovigilance:
    • Act as LDSO according Corporate Octapharma Policy defined by CDSU.
    • Receipt and handling of all adverse events according to Brazilian legislation and act as LDSO of Octapharma Central Drug Safety Unit.
  • Licenses and national and international certifications:
    • Licensing / initial certification, renewals, national inspection of Octapharma Brazil, international inspections of all plants (ANVISA).
  • Distributor Support:
    • Support in all task related with GDP (good distribution Practice) according to European Guideline.
  • CMED:
    • Collaborate in all technical tasks related with price of products registrations.
  • Quality Policy:
    • Maintain SOPs, instructions, organization charts, training updating according to daily events of the Regulatory Department.
  • Your expertise:
    • 3 years experience in similar function.
    • Pharmaceutical's degree.
    • English - excellent written and oral skills.
    • Good grasp of pharmaceutical and biotechnological concepts.
    • Solid knowledge of Regulatory Affairs of biological drugs.
    • Good command of eCTD.
    • GMP and GDP regulation.
    • Highly motivated, Analytical; Independent; Methodic.
    • Team-worker.
    • Self-starter; effective in a highly dynamic environment where priorities can change rapidly.
  • What we offer:
    • Develop and grow a professional career in an exciting, challenging and international environment.
    • You will have a high level of influence where you can make a difference and leave your footprint.
    • Be rewarded with an attractive salary and benefits package.
    • Work with skilled and fun colleagues.

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