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Regulatory Affairs Associate MAA

EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - FULLY FLEXIBLE

Remote:

Full Remote

Contract:

Full time

Experience:

Junior (1-2 years)

Work from:

Mexico

Offer summary

Qualifications:

1-2 years experience in MAA., Experience in CROs preferred., Good English skills..

Key responsabilities:

Manage MA submission and renewals.
Create dossiers for new authorizations.
Handle marketing authorization documentation.
Review SmPCs and PSURs.
Communicate with local health authorities.

Parexel Pharmaceuticals XLarge http://www.parexel.com/

10001 Employees

See more Parexel offers

Job description

Your missions

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are looking for a Regulatory Affairs Associate or Associate with 1 or 2 years of experience in MAA y MTA (marketing authorization application y marketing authorization transfers) preferably developed in CROs.

This role's main activities will be:

Dossier management including MA submission and MA renewals.
Perform new dossiers for new marketing authorizations (local or international).
Handling of documentation for marketing authorization renewals and artwork managing.
Review SmPCs and PSURs.
Communication with local HA and clients.
Respond to any observation from clients or local HA.
Client facing position.
Good English skills.