Career Category

Job Description

Regulatory Affairs Manager :

- Reporting to : Regulatory Affairs Sr. Mgr

- Based in: Cairo, Egypt

We are looking for a Regulatory Affairs Manager for human medicines and biological products. In this role, you will oversee regulatory submissions, ensuring they are compliant with regulations as well as the guidelines set by regulatory bodies.

AMGEN has a wide portfolio with both new and established medicines products and you will be responsible for all aspects of regulatory work for a defined part of the products. The job will include submission of variation, new marketing authorization submission, translation of product information and work with and support AMGEN Global Regulatory Affairs. You will be part of cross functional teams and have close collaboration with marketing, market access, medical and safety teams during registration of new medicinal products and maintenance of existing marketing authorizations.

Your responsibilities include, but not limited to:

• High-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA) and line-extensions.
• Maintain established products according to global and local regulatory plans.
• Update and maintain regulatory databases.

• Handle Health Authorities requests.

• Build and keep a highly professional relationship with the Medicines Agency

• Support and interact with global regulatory affairs, QA, Market Access, marketing (project and product teams) and sales to best support local and global strategy and interest for development projects and marketed products and ensure adequate communication with relevant stakeholders

• Monitor future trends in regulatory issues which are likely to affect AMGEN interest. Share information with colleagues if appropriate.

• Perform or facilitate audits to ensure compliance

Background/Experience

• A bachelor’s degree in Pharmacy

• Excellent medical English
• 4 years of regulatory experience in the pharmaceutical industry or with Health Authorities.
• Strong oral and written communication skills.
• Excellent current regulatory knowledge understanding of US FDA and EMEA regulatory guidelines.
• Advanced ability to interpret scientific data and to construct persuasive regulatory documents.
• Good communication skills, ability to work effectively in a matrix setup
• Strong knowledge of regulatory life cycle maintenance.
• Having People Management experience is critical.
• An analytical approach balanced with a keen eye for detail demonstrated in all document control and administration undertaken. High degree of computer literacy in the use of both scientific and other role related software applications.
• Strong communication and leadership skills with the ability to select, motivate, train, and develop staff to achieve both company and personal goals.
• Proven track record in the delivery of regulatory, technical, and scientific projects.

The job in Regulatory Affairs requires that you:

• Work independently.
• Pay attention to details.
• Is flexible but persistent and take the initiative to get the job done.

• Have a positive approach to life and manages to keep many balls in the air without losing either the big pictures or deadlines - even when things go fast