Career Category

Job Description

Group Purpose

Facilitate patient access to Amgen products in Intercontinental countries through executing on our Intercontinental filing plan; providing strategic regional regulatory guidance on regional regulatory mechanisms to optimize product development  and approvals; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent.

Job Summary

Planning and managing local regulatory submissions in Mexico and LATAM Dist. Markets in compliance with corporate standards and local regulatory requirements.

Supervise and work closely with distributors to execute regulatory strategies in the region

Act as a contact with regulatory agencies in fulfilling local marketing authorization obligations

Assist in aligning local regulatory requirements with Amgen’s corporate standards

Provide regional input to & execute regulatory strategies

Key Activities

Strategic and Execution
• Ensure regulatory submissions are made on time and meet Amgen’s corporate and local regulatory requirements. 
• Contribute to and implement, execute the filing plan for their countries where applicable
• Review & approval of source text for country labeling, and owners of country artwork based on source text
• Review and approval of promotion and non-promotion materials
• Monitor changes in local trade Associations, Code and national legislation and forward information to local /regional/reg intel groups and feedback into strategy in a timely manner

Regional Specific Activities
• Assist locally in Healthcare Compliance activities where applicable
• Input into the affiliate / local office compliance framework to ensure complies with local codes and legislation and Amgen policies
• Disseminate relevant information to team as appropriate
• Participate in local regulatory process improvements initiatives and training
• Where applicable oversee external vendor/contractor relationships

Collaboration
• Collaborating with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate)
• Exchange regulatory information & intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
• Partner where required with Regional Regulatory Leads (RRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.

HA Interaction
• Under general supervision participates in regulatory activities to ensure effective local agency interactions
• Act as a contact where appropriate with regulatory agencies in fulfilling local obligations by product assignment

Knowledge and Skills
• Regulatory principles (Mexico and LATAM countries)
• Working with policies, procedures and SOP’s
• Knowledge of national legislation and regulations relating to medicinal products
• Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals.
• Knowledge of drug development

Scientific / Technical Excellence
• Team work
• Communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and prevent potential issues
• Knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Understanding of regulatory activities and their touch points
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional, country and International borders.

Education & Experience

• Bachelor’s degree and in-depth regulatory experience related to IC region.

• Knowledge of IC countries legislation and regulations relating to medicinal products

• Knowledge of drug development Scientific / Technical Excellence

• Team work

• Communication skills both oral and written

• Ability to understand and communicate scientific/clinical information

• Cultural awareness and sensitivity to achieve results across both regional country and International borders