JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:
- Career development with an international company where you can grow the career you dream of.
- An opportunity to work in a dynamic and diverse environment, spanning multiple product categories and emerging markets.
- A collaborative, cross-functional setting that fosters teamwork and innovation.
- Part of a team with highly skilled and experienced regulatory affairs professionals.
- A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Egypt office location in the Abbott EPD division, focusing on pharmaceutical products.
As the EM CMC Strategy lead , you’ll have the chance to [insert key responsibilities and tasks].
What You’ll Work On
- Lead CMC regulatory strategy for product localization, remediation, and technical transfers involving formulation
- Act as CMC submission lead throughout the product lifecycle, ensuring compliance through regulatory filings and post-approval variations
- Support due diligence
Experience :
· Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field; Master’s degree preferred
. Minimum 7 years experience in Emerging markets regulatory preferably with a Multinational Company
· Strong expertise in CMC regulatory strategy, dossier evaluation, CMC remediations and product registration across emerging markets
· Proven ability to manage complex regulatory projects with minimal supervision and cross-functional collaboration
Preferred Qualifications
- Recent experience on CMC in the emerging markets
- Led tech-transfer activities
- Cross-regional experience
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
EPD Established Pharma
LOCATION:
Egypt > Cairo : KTC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
No
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable