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Regulatory Affairs Analyst (Temporally)

Long Description

Join us as Our Temporally Regulatory Analyst!

OBJECTIVE:

This temporally Regulatory Affairs Analyst will support in the creation of dossiers for submission to regulatory authorities and will support RA Coordinator to update the different compliance systems.

It will ensure that all regulatory activities are executed and completed in accordance with best practices and regulatory compliance in a consistent manner in all projects. It will carry out a wide and close management with the areas of supply, R&D, HME, Mkt, etc.

Long Description

ACTIVITIES:

Supports on the assembly and delivery of dossiers for OTC or SWB products, including technical and / or administrative variations, renewals or any other procedure that must be submitted to the Authority within the agreed timings.

Guarantees high quality and precision in the dossier’s vs agreed requirements and indicate on any potential issue that considers a risk for the purpose of the project working together with the areas that elaborate the documents.

Supports all the work required to improve the regulatory processes and procedures that optimize the efficiency and precision of strategies for rapid access to the market: actively participates in brainstorming ideas for marketing claims and product name ideas and works in the maintenance of Import Permits according to dates and amounts.

Ensures the Regulatory Compliance maintaining the global regulatory systems of dossier packages and licenses records updated.

Long Description

REQUIREMENTS:

Bachelor in Pharmaceutical Chemistry (QFB, QFI, LF or similar).

Regulatory Affairs, Quality, Safety.

Fluent in English

Pharmaceutical experience.

Knowledge of the Consumer Healthcare regulatory environment.

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 

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