Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Senior Manager - Regulatory Affairs ELI based in Cairo, Egypt

Live - What you will do

Let’s do this. Let’s change the world. In this vital role you will act as the Local Regulatory Affairs Lead and will provide regulatory leadership, expertise, and execution in ELI (Egypt Levant Iran) cluster for the development, registration, and lifecycle management of all Amgen molecules.

Responsibilities:

• Ensuring that the local GRAAS staff in country delivers on local and/or regional regulatory strategies and goals for assigned products within their country/region.
• Providing strategic regional input to developing and executing regulatory strategies and effective key regulatory agency interactions, establish network and relationships with distributors, QC labs and industry associations working groups
• Will perform supervisory oversight for one or more regulatory staff
• The role may include management and collaborating closely with external stakeholders, will be a key partner at ELI leadership management team providing key insights and guidance to achieve business goals

Key Strategic Activities and Execution:

• Translates global and regional business plans to local regulatory and quality objectives
• Contribute to and execute filing plan for ELI countries where applicable
• Provide local expertise to evaluate and achieve regulatory success based on proposed strategies
• Responsibility to ensure appropriate review and approval of promotion materials
• Monitoring and communicating regulations for labeling (RPI, PIL, PCL) and overseeing their implementation
• Review of source text for country labeling
• 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 Management
• Where applicable recruit, manage and retain talented regulatory staff.
• Where applicable provide coaching, mentoring and development of staff.
• Disseminate relevant information to local cross function teams as appropriate
• Provide input to budget and headcount planning
• Participate in local regulatory process improvements initiatives and training Collaboration
• Where applicable collaborating with Global Study Operations (GSO) to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements
• Input into local implementation of key regulatory projects
• 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 international Regulatory Leads (IRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules. External
• Managing vendors and ongoing relationship as required
• Monitor changes in local trade Association, Code and national legislation and forward information to local /regional/reg intel groups & policy team and feedback into strategy and TAs HA interaction
• Attends HA meetings as required
• Participates in local industry and trade association groups relating to Amgen business activities and Regulatory Affairs Compliance Input into the development and implementation of any country specific compliance procedures

Win - What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is an individual with the following qualifications:

Educational Background:

Doctorate degree / Master’s degree / Bachelor’s degree in a related subject

• Proven relevant experience within regulatory environment from another multinational pharmaceutical or life sciences company.
• A minimum of 2 years of direct managerial and/or leadership experience conducting regulatory submissions.
• Demonstrable experience interacting with regulatory agencies
• Excellent communication skills - both oral and written language in English, Arabic and preferably French
• Ability to understand and communicate scientific/clinical information
• Understanding of local regulatory activities and how they affect projects and processes
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness
• Ability to input optimally on multi-functional teams.
• Ability to anticipate and prevent potential issues
• Understanding of drug development
• Regulatory knowledge for assigned country and/or region
• Working with policies, procedures, and SOP’s

Thrive - What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• A Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now - for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.