Regulatory Affairs Specialist

Purpose: Ensures regulatory internal and external compliance of Bayer´s submissions from technical, legal and administrative perspective for the products of the Pharmaceuticals division of Mexico.

Scope: Regulatory Affairs, Pharmaceuticals division of Mexico.

Key Tasks:

Provides regulatory support for the maintenance lifecycle management of the products of the Pharma Portfolio such as submissions on time and of complete dossiers “right at the first time” for renewals, and variations (administrative, technical and safety related), artwork reviews and support to other end-to-end regulatory activities. 

Responsible for ensuring the regulatory compliance and accomplishment of local and global KPIs of the Mexican regulatory team.

Provides strategic regulatory support and advice to the regulatory team and internal stakeholders with an effective communication and collaboration to remove obstacles from submission preparation process and support the team in rapid fillings and responses to Health Authority Questions.

Key Working Relationships:

Local Functions: Regulatory Affairs, Product Supply, Medical Affairs, Business Units, QA, Pharmacovigilance, Clinical Operations, Market Access and Manufacturing Sites.

Regional Functions: Regional Regulatory Affairs Managers, Regional Operations Specialists.

Global Functions: Global Regulatory Affairs (Labeling, CMC, Document office).

Skills & Qualifications:

Degree in Pharmaceutical Science or related field.

Demonstrated senior regulatory experience within the pharmaceutical industry in navigating, interpreting and submitting complex dossiers for high specialty pharmaceutical medicines.

Strong overview and knowledge of the current Mexican regulatory environment and regulations (medicines, biologics, orphan drugs).

Strong verbal and written communication skills in English in at least a B2 level.