HUIXQUILUCAN, Mexico
7 days ago
Regulatory Affairs Research Specialist - Temporary

Job Location

MEXICO CITY GENERAL OFFICE

Job Description

Temporal position in the local P&G Health Regulatory (RA) team to perform regulatory activities for a relevant project that include several variation dossiers of P&G medicinal / medical device products and support direct manager on associated activities to execute the assigned project in other product categories, including food, cosmetics and sanitizer   of P&G healthcare products.
 

Perform the necessary regulatory tasks in Mexico to execute assigned project that include several variations to the product license of various P&G Health products.

Review and compile administrative dossiers, ensuring compliance with regulation and P&G requirements to achieve rapid and successful approval.

Track of submission and approvals, execute the preparation and conduct the review of responses to questions raised by the regulatory authorities.

If needed, assist manager in development of associated strategies and assessments.

Provide maintenance work on associated post-approval change for the assigned project

Upload product regulatory documents and information in the proper systems, including  DIGIPRIS (External Board of Health platform) and internal systems.

Develop LC / Marbetes in accordance to local regulation and P&G needs informed by direct manager

Review and approve artworks following the local rules and internal  procedures

Closely collaborate with other areas and cross functional teams under the assigned project

Job Qualifications

Chemical Pharmacy science degree or equivalent in terms of industrial experience

At least 1.5 years of regulatory experience, preferably in healthcare areas

Regulatory Medicinal experience in Mexico.

Job Schedule

Full time

Job Number

R000121854

Job Segmentation

Experienced Professionals (Job Segmentation)
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