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Regulatory Affairs Specialist

hace 2 meses

Bogotá, Bogotá D.E., Colombia Takeda Pharmaceutical A tiempo completo
About the Role

This is a challenging and rewarding opportunity to join Takeda Pharmaceutical as a Regulatory Affairs Specialist. As a key member of our team, you will play a critical role in supporting the business strategic plan to obtain Marketing Authorizations, renewals, and variations for existing and new products.

Key Responsibilities
  • Support the submission of pharmacological, technical, and legal dossiers for Marketing Authorizations, renewals, as well as Marketing Authorizations amendments for products in the portfolio and for new products.
  • Provide support to prepare regulatory responses to resolve agency questions on time.
  • Lead the process to maintain clinical urgencies submissions (NPPs).
  • Execute the MA renewal planning.
  • Maintain follow up with the local Health Authorities to obtain the approvals according with the RA planning.
  • Complete on time the assigned trainings.
  • Review and approve local labelling material.
  • Support (if required) creation of LCRs and RFM requests.
  • Evaluate CCDS changes and submit at local level according with corporate timelines.
  • Keep on track regulatory submissions, and define strategies to comply with expected approval dates.
  • Artwork review and approval.
  • Promotional and non-promotional materials review and approval.
  • Attend meetings with Health Authorities.
  • Enhance the operational performance and quality output through continuous process improvement.
  • Identify, align, and implement risk mitigation strategies for all regulatory processes.
  • Perform regulatory intelligence strategy for Colombia by monitoring of regulatory status for competitors and monitoring, assessing impact and scaling up of new regulations.
  • Ensure regulatory systems and databases are timely maintained and perform the Monthly Reports.
  • Maintain the local RA SOPs updated according with the new regulations.
  • Coordination of Trainings for Newcomers.
  • Support on audits & follow up on CAPAs.
  • Compliance of internal policies.
Requirements
  • Bachelor's degree preferably of Pharmacist.
  • Solid knowledge of drug products (small molecules and biologics) and medical devices regulations in Colombia.
  • Minimum 5 years' experience in Regulatory Affairs, focus biological and biotechnological products.
  • Advanced-level English.
Competencies and Skills
  • Strategic thinking.
  • Multidisciplinary team working experience.
  • Teamwork and communication.
  • Focused on the customer.
  • Management problem solving skills.
  • Business acumen.
  • Research and good teamwork skills.
  • Results oriented.
  • Committed to foster a diversity, equity, and inclusive environment.