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Senior Regulatory Affairs Professional
hace 2 semanas
**About Us:** Belab Services - Regulatory International Experts is a dynamic and growing company that offers a unique opportunity for professionals looking to excel in the field of regulatory affairs.
We are currently seeking a highly experienced Regulatory Affairs Specialist to join our team and contribute to the success of our clients in the cosmetics, OTC, and dietary supplement industries.
As a Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance for our clients' products in the U.S. and Canadian markets. This includes preparing, submitting, and managing regulatory documentation to obtain approvals from regulatory bodies such as the FDA and Health Canada.
The ideal candidate will have a strong educational background in Chemistry, Pharmacy, or a related field, along with in-depth knowledge of regulatory requirements set by authorities such as the FDA, Natural Health Products (NHP), 510(k) submissions, and more.
This is a remote position, with preference for candidates based in Spain or those who are willing to work remotely.
Key Responsibilities:
- Ensure regulatory compliance for cosmetic, OTC, and dietary supplement products in the U.S. and Canadian markets.
- Prepare, submit, and manage regulatory documentation to obtain approvals from regulatory bodies such as the FDA and Health Canada.
- Collaborate with internal and external teams to ensure regulatory compliance throughout all product development and commercialization phases.
- Stay updated on changes in regulations and applicable compliance requirements.
- Provide regulatory advice and support to various departments within the company.
- Oversee and coordinate audits and certification processes as required.
- Collaborate with the regulatory team on other regulations (EU, UK, etc.).
Requirements:
- Bachelor's or Master's degree in Chemistry, Pharmacy, or a related field.
- Minimum of 3 years of experience in Regulatory Affairs within the cosmetics, OTC, and/or dietary supplement sectors.
- Strong knowledge of FDA, NHPS, 510(k) submissions, and other relevant U.S. and Canadian regulations.
- Excellent analytical and documentation management skills for regulatory submissions.
- Fluent English (spoken and written) is a must.
- Strong communication and teamwork skills.
- Ability to work independently in a remote environment.
- Motivated person eager to work, open to learning and enthusiastic about building a career in a leading company.
