ROCHE: PTR International Operations Associate (contrato a término- aprox. 1 año-)

Para: Laboratorio ROCHE

Ref. R6014
Localidad: WTC, Montevideo


A proactive, curious and willing to learn candidate, ready to join a multicultural team.
The candidate will interact with a diverse group of experts, in a competitive, motivating and dynamic work environment.
Advance student or academic degree in relevant technical area (Analytical, Biochemistry, Biology, Pharmacy, among others).
A minimum of 2 years of experience in the pharmaceutical industry is desirable.
Experience in Regulatory Affairs with focus on CMC requirements for small molecule/biologic products, development, manufacturing and/or quality assurance would be an asset.
Previous knowledge of ICH guidelines, GMPs, global regulations and health authority guidance would be valuable.
Proficient in Microsoft Office.
Fluent written and oral English area required.
Ability to travel up to 10%.

Objetivo de la posición

You are responsible for renewals submissions for all Roche products through developing and implementing robust end to end strategies of the local filings based on global plan, global/regional/local business priorities, local regulatory requirements and landscape to accelerate drug access and continuous supply to the patients by ensuring right first-time submissions to Health Authorities.
You are the Pharma Technical Regulatory (PTR- CMC) contact for International Markets Renewals filings, partnering with global PTR teams helpings to develop and execute regulatory filing strategies for renewal approvals by Health Authorities.
You act as the subject matter expert in CMC regulatory requirements for submissions and assure maintenance of regulatory requirements for markets under responsibility.
In collaboration with PDR ERAS, you help to develop and execute objectives and plans toward aligning one global regulatory voice/outlook to affiliates in the region.
You support departmental operational excellence and business process initiatives.
Is responsible to define path to organize the processes under which renewals will be performed either by Submission Expert or outside the system.

What we offer:

Opportunity to learn and grow in the field of international regulatory affairs.
Dynamic exchange with worldwide Roche affiliates, supply chain, quiality and policy departments.
Enrichment of interpersonal communication skills through participation in expert meetings and internal seminars.
Support to acquire training in new areas of operation.
Bidirectional feedback on performance.
Protected environment for the exchange of new ideas.

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Más Oportunidades

Ref. R6027

Localidad: WTC, Montevideo - Uruguay

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