Career Category

Job Description

Regulatory Affairs Manager

Job Summary:

• Planning and managing local regulatory submissions in compliance with
corporate standards and local regulatory requirements.
• Act as 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

• Extensive experience in regulations for LatAm, technical knowledge in particular for countries that deal with distributors, + 5 years at least in that position.
• Good level of oral and written English.
• Robust skills in assertive oral and written communication, strategic thinking, effective decision making, team management, conflict management, high capacity to delegate & prioritize.
• Ability to handle several projects at the same time.
• Good relationship and connection with external actors i.e. dealers.

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 the 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 the 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
• Working with policies, procedures,and SOP’s
• Knowledge of national legislation and regulations relating to medicinal
products
• Awareness of the registration procedures in the region for MA, post-approval
changes, extensions, and renewals.
• Knowledge of drug development

Scientific / Technical Excellence
• Teamwork
• 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 the regional regulatory environment in relevant
product area and development stage
• Understanding of regulatory activities and their touchpoints
• 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

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

Amgen no discrimina en sus oportunidades de empleo por razón de sexo, raza, color, edad, origen nacional, por ideas políticas o religiosas, género, orientación sexual, identidad de género, nivel y tipo de discapacidad, origen étnico, o por cualquier otra categoría protegida por ley.

Amgen does not discriminate in its employment opportunities on the basis of sex, race, color, age, national origin, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law.