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 compliance with
corporate standards and local regulatory requirements.
• Act as a contact with regulatory agencies in fulfilling local marketing
authorisation 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 country 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
• Contribute to and execute filing plan for their country where applicable
• Monitor changes in local trade Association, 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 Knowledge and Skills
• Regulatory principles
• 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
(Basic) Doctorate degree
OR
Master’s degree and 3 years of directly related experience
OR
Bachelor’s degree and 5 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience
Education & Experience
(Preferred)
oBachelor’s degree and in-depth regulatory experience related to IC region.
oKnowledge of IC countries legislation and regulations relating to medicinal
products
oKnowledge of drug development Scientific / Technical Excellence
oTeam work
oCommunication skills both oral and written
oAbility to understand and communicate scientific/clinical information
oCultural awareness and sensitivity to achieve results across both regional
country and International borders

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.