Amgen Sr. Associate Regulatory Affairs in Bogota, Colombia

#LI

Work location: Bogota

Job description:

  • Local coordination and execution of regulatory submissions in compliance with corporate standards and local regulatory requirements.

  • Management and execution of the preparation, delivery and electronic archiving of documentation for inclusion in local regulatory submissions.

  • Coordination and execution of Regulatory Affairs processes and deliverables in the local office.

  • Coordinate Promotional and non promotional review process.

  • Ensure regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements.

  • Contribute to and execute the filing plan for their country where applicable

  • Review source text for country labeling

  • Review promotion and non-promotion materials

  • Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy

  • Disseminate relevant information to team(s) as appropriate

  • Participate in local regulatory process improvements initiatives

  • Assist locally in Healthcare Compliance activities where applicable

  • Coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies.

  • Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.

  • Coordinating translation for local Regulatory submission.

. Coordinating review of promotional and non promotional materials

REQUIREMENTS :

  • Residence in Bogota -REQUIRED

  • Degree in pharmaceutical chemistry -REQUIRED

  • Experience in pharma industry with minimum of 5 years in similar roles -REQUIRED

  • Desirable experience with biological products

  • Fluency in English -REQUIRED