MEA 法规事务高级专员

Career Category
RegulatoryJob 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.

Job purpose:

• As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.

Job Responsibilities:

• Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics

• Manage Performance Excellence through collection, analyzing & disseminating relevant information to team(s) as appropriate

• Participate in local regulatory process improvements initiatives

• Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics

• Ensure delivery of right first time label source text for artwork creation

• Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner

• Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region

• Access the translation agency systems to request the label translation and track the job readiness and timelines.

• Perform regional prescribing information translation review: 100% review of both content and format

• Perform the role of source text owner/approver and artwork reviewer/approver in the system

• Trigger the existing label revision when alerted by global RA team.

• Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)

• 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.

Qualifications:

• Experience +2 years in Regulatory Affairs

• Current/ previous experience in working as part of an MNC employer

• Pharmacist, biologist, chemist-medical background

• Fluent in English and Arabic for translation review purpose ( French is a huge plus)

• A minimum knowledge of Middle East Africa regulatory requirements

• Strong communication skills (verbal & written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues

• Conflict Management skillset & ability to deal with multiple stakeholders simultaneously.

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

• Generous 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.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, 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.
.Originally posted on Himalayas