Regulatory Affairs Specialist

Regulatory Affairs Specialist

Responsible for ensuring that the organization's activities are conducted ethically and in compliance with relevant regulations, laws, and standards. Develops and implements regulatory strategies, procedures, and controls for new products and/or business activities that require governmental approvals. Prepares and submits regulatory applications such as permits, licenses, certificates, and authorizations required by governmental agencies. Coordinates government interactions and compliance activities and interacts with regulatory agencies.

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.

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Bayer Is committed to providing access and reasonable accommodations in its applications process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodations when the recruiter contacts them for the process.

Período de aplicación:

07 al 21 de Julio

Código de referencia:

875931

División:

Pharmaceuticals

Ubicación:

Mexico : Ciudad de México : Ciudad de México

Área funcional:

Registro Farmacéutico

Grado de posición:

unknown

Permanente

Tiempo de trabajo:

Full TIme - Hibrido