Job Description

States considered:

Role

The Regulatory Affairs Coordinator will be responsible for executing administrative processes such as: Payments needed for submission purposes before SADER, PROFECO and COFEPRIS; management of payments, contracts of suppliers; filling information of internal systems.

The Regulatory Affairs Coordinator will coordinate compliance-related processes with authorities, such as: Monitoring and recording the receipt of prescriptions (Bios and Pharmas Group I and II); coordinating and participating in official inspections (including, but not limited to annual inspections, inspections of advertising materials, and product destruction); coordinating the receipt of reports of APIs used by third parties; reviewing advertising materials; creating and/or reviewing and submitting mandatory sales reports (Bios and Pharmaceuticals Group I); and creating and submitting import permits (Pharmaceuticals Group I).

The Regulatory Affairs Coordinator will train local team about regulations applicable to prescriptions and advertising materials.

The Regulatory Affairs Coordinator will coordinate the registration processes for Pharmaceuticals, Bios and Diagnostic kit products.

The Regulatory Affairs Coordinator will review artworks to ensure compliance.

The Regulatory Affairs Coordinator will keep Establishment Licenses up to date with SADER and COFEPRIS.

The Regulatory Affairs Coordinator will oversee compliance of the Affiliate´s authorized veterinarians and warehouses.

The Regulatory Affairs Coordinator will request documents needed for submission purposes before SADER.

The Regulatory Affairs Coordinator will create packaging material texts and files for submission purposes before SADER, COFEPRIS and PROFECO (variations, renewals, new licenses).

The Regulatory Affairs Coordinator will provide documentary support to customers, in compliance with local regulations.

Main Responsibilities

The Regulatory Affairs Coordinator will be primarily responsible for the following activities, including but not limited to:

• Oversee the compliance of monthly objectives previously defined by the Regulatory Affairs Manager to meet approval timelines for new registrations, transfers and variations.
• Manage administrative processes in compliance with local regulations and internal policies (e.g. supplier payments and contracts, and recording regulatory information in internal systems).
• Coordinate processes required by local regulations related to prescriptions, advertising materials, inspections, mandatory sales reports, and import permits.
• Train colleagues on regulations related to prescriptions and advertising materials.
• Coordinate activities required to conduct local testing, prepare and submit dossiers for new pharmaceutical, bios and diagnostic kit products.
• Review artworks in accordance with global procedures and local regulations.
• Identify changes impacting Establishment Licenses and coordinate actions needed to keep them up to date with SADER and COFEPRIS, including Authorized Veterinarians Licenses.
• Identify documents required for submissions to SADER, request them and prepare the files needed for submissions to SADER, COFEPRIS and PROFECO.
• Creating letters, providing licenses and packaging materials to customers according to local regulations, ensuring internal compliance.

Qualifications (Training, Education & Prior Experience)

Education:

• Undergraduate degree in Veterinary Medicine or related professional fields.
• Command of English is mandatory.

Experience:

• 5 Years of experience in regulatory affairs for veterinary product registration SADER, COFEPRIS and PROFECO (desirable).
• Experience attending official verifications.

Systems and Tools Required:

• Computer skills: Highly capable in MS Office, including Excel, Word and PowerPoint & Experience managing systems such as ETS, APS Streamlink (SAP) and Veeva Vault desirable.

Other Commentaries

English level: Advanced command of English is mandatory.

Preferred place of residence: CDMX

Availability for business travel and/or relocation: Availability for business travel.

Full timeRegularColleague

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