Career Category

Regulatory

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.

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

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Job purpose:

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 UsAs 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

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.

MEA Regulatory Affairs Sr Associate at Amgen