Amgen Sr. Associate Regulatory Affairs in Bogota, Colombia
Work location: Bogota
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
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