Regulatory Affairs Leader

Be part of the change with Birdman!

In Birdman, we create plant-based foods that care for the planet and people.

We are looking for talent with technical leadership, passion for quality, and commitment to food safety, for a key role in our quality control team.

Role objectives:

• Develop and implement processes to ensure regulatory compliance of products and processes related to health.

• Manage and integrate legal and technical documentation to support regulatory compliance of products, services, and countries.
• Liberation of formulas and product arts according to the regulations of the target country for the sale of the product.
• Attention to government agency audits and ensure regulatory compliance of products and processes.
• Maintain certifications and lead the implementation/obtaining of new certifications

Functions and responsibilities:

In general:

• Regulatory process management (COFEPRIS, FDA, etc).

• Preparation of files with legal and technical documentation for each product and process to ensure regulatory compliance.
• Review of arts against applicable regulations for their release to production.
• Review of formulas against applicable regulations for their release to production.
• Update of procedures and regulations according to the update of applicable regulations.
• Attention to government agency audits.
• Review of technical documents (specifications, monographs, standards, etc.)
• Monitoring of national and international norms for the detection and implementation of new legal requirements

Requirements:

Education:

• Bachelor's degree in biotechnology, chemistry, food science or related fields.

Experience:

• 4 years in the dietary supplements, medical devices or pharmaceuticals industry

• 2 years in regulatory management in dietary supplement or pharmaceutical companies.
• New product launches in Mexico/USA
• National and international regulations for introducing new products to countries.
• Experience with regulatory requirements in Mexico and the USA.
• Knowledge and management of procedures before government agencies
• Legal requirements in health matters, national and international. COFEPRIS/FDA
• Knowledge of official Mexican norms ISO, COFEPRIS, NOM

Experience Plus:

• US regulations, FDA
• Sanitary responsible
• Management of procedures before Cofepris for exportation