Technical Regulatory Sr. Associate
3 days ago
3803 Viatris Egypt S.A.E
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Technical Regulatory Senior Associate role will make an impact:
Key responsibilities for this role include:
- Managing weekly EDA inspector and communicating with all stakeholders on any received correspondences/EDA inquiries
- Liaising with EDA inspector and prepare documents for API/semi-finished seal break
- Maintain compliance with EDA decrees & Viatris guidelines
- Submission of NODCAR files to NODCAR
- Pulling samples (FG/APIs) for NODCAR analysis/random inspection sampling/etc
- Arranging for EDA inspector transportation
- Delivering samples to NODCAR and paying fees
- Following up on conformance reports samples with NODCAR
- Delivering and receiving correspondences to/from NODCAR
- Coordinating any EDA audits on site and communicating any outcomes to site/EDA
- Initiate and manage regulatory CCRs
- Creation of QQFs & Follow up on its review and approval with QO
- Requesting Codes for New artworks
- Requesting and compiling quality related documents from site departments for regulatory filings
- Preparation and review of Files to be ready for submission (stability file, NODCAR files, etc.)
- Owning artwork implementation process driven by regulatory
- Preparation of cover letter for destruction certificates and liaising with inspector for scheduled destructions
- Requesting CoAs from QC
The minimum qualifications for this role are:
- Bachelor’s degree in Pharmaceutical Sciences
- Minimum 3 years of experience in regulatory or compliance department & experience with EDA inspection department is preferred
- Good command of English both written and spoken
- Free from governmental employment
- Proficient knowledge in EDA Inspection requirements
- Good knowledge of Regulatory and EDA requirements
- Knowledgeable with interpersonal learning
- Good Communication skills
- High Precision and Accuracy
- Decision making skills
- High analytical skills
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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