Regulatory Affairs Leader
hace 2 meses
Are you prepared to make a significant impact?
About Birdman: At Birdman, we are at the forefront of creating a sustainable future by transforming food consumption with our range of healthy, delicious, and cruelty-free plant-based products. With a remarkable track record of 100% year-over-year growth for eight consecutive years, we are set to explore new markets and launch innovative business lines, aiming to reach new heights while maximizing our positive impact on the environment.
Position Overview: As a Regulatory Affairs Specialist, your primary responsibility will be to evaluate our products and processes to ensure compliance with both national and international regulations. You will compile essential technical and regulatory documentation for each product, conduct label reviews, and manage interactions with various government agencies. Additionally, you will establish processes to promote continuous improvement in regulatory compliance. If you have a passion for regulations and standards, this role is tailored for you.
Ideal Candidate Profile: The successful candidate will elevate the regulatory compliance of our products. You should possess a strong understanding of national and international regulations, experience with government agency interactions, and a keen eye for detail when reviewing the regulatory compliance of new products.
Key Responsibilities:
- Develop and implement processes to ensure the regulatory compliance of manufacturing and products.
- Manage and integrate regulatory and technical information to support compliance efforts.
- Review and approve new product formulas and labels in accordance with applicable regulations.
- Oversee interactions and proceedings with various health-related government agencies.
- Maintain existing certifications and lead efforts for new regulatory certifications.
- Review technical documents, including specifications and standards.
- Continuously monitor updates to national and international regulations to ensure compliance.
Qualifications:
- Minimum of 4 years of experience in the dietary supplements, medical devices, or pharmaceutical sectors.
- At least 2 years of experience specifically in regulatory affairs within these industries.
- Proven experience with government agency interactions.
- Exceptional writing skills.
- Familiarity with Mexican regulations.
- Understanding of FDA requirements.
- Knowledge of regulatory requirements for exporting products.
- Experience with COFEPRIS audits is a plus.
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