Urwah Admin

Viatris

<div>Viatris Egypt S.A.E<div></div><div>
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.<br>
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Viatris empowers people worldwide to live healthier at every stage of life.<br>
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We do so via:<br>
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Access &ndash; Providing high quality trusted medicines regardless of geography or circumstance;<br>
Leadership &ndash; Advancing sustainable operations and innovative solutions to improve patient health; and<br>
Partnership &ndash; Leveraging our collective expertise to connect people to products and services.</div><div><br>
Every day, we rise to the challenge to make a difference and here&rsquo;s how the (Regulatory Affairs Senior Associate) role will make an impact:</div><div><br>
Key responsibilities for this role include:</div><ul><li><div>
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.</div></li><li><div>
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.</div></li><li><div>
Responsible for enhancing relationships with key external agencies (Egyptian Drug authority EDA). Manage the EDA interface throughout the development and lifecycle of a product.</div></li><li><div>
Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP&rsquo;s and systems are followed.</div></li><li><div>
Ensure a submission planning and forecasting tool is utilized to update timelines, when necessary, communicate changes to relevant partners.</div></li><li><div>
Capable of authoring some local submission components in relevant databases.</div></li><li><div>
Ensure submission packages are reviewed against local CMC requirements for consistency and completeness.</div></li><li><div>
Liaise with the manufacturing sites for obtaining supporting documents as needed.</div></li><li><div>
Participate in local and regional regulatory initiatives promoting a culture aligned with Viatris values and which supports compliance, innovation and talent development and retention.</div></li><li><div>
Maintain compliance with the regulatory systems, processes and procedures.</div></li></ul><div></div><div>
The minimum qualifications for this role are:</div><ul><li><div>
2-3 years of experience in regulatory affairs, preferably in human medicines.</div></li><li><div>
Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.</div></li><li><div>
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards.</div></li><li><div>
Demonstrate experience of effective delivery in a matrix environment.</div></li><li><div>
Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.</div></li><li><div>
Knowledge of drug development, regulations, and guidelines.</div></li><li><div>
Knowledge and understanding of quality systems and processes.</div></li><li><div>
Ability to influence peers in the organization.</div></li><li><div>
Team player.</div></li><li><div>
Act independently with less supervision.</div></li><li><div>
Analytical thinking.</div></li></ul><div></div><div>
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.</div><div></div><div>
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.</div><div></div><div>
Viatris is an Equal Opportunity Employer.</div></div><div></div>

Regulatory Affairs Senior Associate

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Viatris

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Regulatory Affairs Senior Associate