Regulatory Affairs Senior Associate

Job Summary

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 heres how the (Regulatory Affairs Senior Associate) role will make an impact:

Key responsibilities for this role include:

• Support the local regulatory team in the development of regulatory strategies to support the registration of new products line extensions major variations and lifecycle management.

• Develop strong partnerships with in-country and above country teams to facilitate the development and implementation of registration strategies to expedite the registration of new products line extensions and life-cycle optimization.

• Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.

• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes SOPs and systems are followed.

• Ensure a submission planning and forecasting tool is utilized to update timelines when necessary communicate changes to relevant partners.

• Capable of authoring some local submission components in relevant databases.

• Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.

• Liaise with the manufacturing sites for obtaining supporting documents as needed.

• Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance innovation and talent development and retention.

• Maintain compliance with the regulatory systems processes and procedures.

The minimum qualifications for this role are:

• 2-3 years of experience in regulatory affairs preferably in human medicines.

• Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.

• Proven ability to manage Regulatory issues and consistently deliver to time cost and quality standards.

• Demonstrate experience of effective delivery in a matrix environment.

• Technically competent to understand CMC submissions interpret and communicate requirements and identify potential risks.

• Knowledge of drug development regulations and guidelines.

• Knowledge and understanding of quality systems and processes.

• Ability to influence peers in the organization.

• Team player.

• Act independently with less supervision.

• Analytical thinking.

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.

At Viatris we offercompetitivesalaries benefitsandan 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.

Required Experience:

Senior IC

Key Skills

• Proofreading
• Adobe Acrobat
• FDA Regulations
• Manufacturing & Controls
• Biotechnology
• Clinical Trials
• Research & Development
• GLP
• cGMP
• Product Development
• Chemistry
• Writing Skills

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