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Regulatory Affairs Consultant for Healthcare Products
2 meses atrás
Job Title:
Regulatory Affairs Consultant
Location:
Brazil
Job Overview:
We are looking for a knowledgeable and proficient Regulatory Affairs Consultant to become a vital part of our team at ClinChoice.
The successful candidate will possess a comprehensive understanding of the regulatory environment concerning synthetic pharmaceuticals, herbal products, dietary supplements, and medical devices.
This position is essential for guaranteeing that our offerings adhere to all pertinent local and international regulations, allowing us to provide safe and effective solutions to our clientele.
Key Responsibilities:
- Assess promotional materials, brochures, and product labels as needed.
- Facilitate the submission of documentation prepared by senior team members.
- Assemble general documentation (notifications for brochures and labels, requests for official certifications, and data correction requests).
- Conduct MC/LC control as part of the leaflet and label modification process.
- Manage post-submission and post-approval tasks (complete systems and notify internal teams).
- Assist in the certification processes for good manufacturing practices of production facilities (review forms and submit).
- Keep track of regulatory updates from Anvisa and inform the local regulatory team.
- Oversee regulatory activities related to Direct to Consumer (Over the Counter) products.
Qualifications:
Bachelor's degree in Pharmacy, Chemistry, Biology, or a related discipline; an advanced degree is preferred.
A minimum of 4 years of experience in regulatory affairs within Brazil, particularly with ANVISA, focusing on synthetic pharmaceuticals. Experience with herbal products, dietary supplements, and medical devices is advantageous.
In-depth understanding of ANVISA regulations and guidelines, along with international regulatory standards.
A proven history of successful regulatory submissions and approvals.
Strong analytical, problem-solving, and decision-making capabilities.
Excellent communication, negotiation, and interpersonal skills.
Fluency in Portuguese and English, both written and spoken.
Additional Skills:
Ability to thrive in a fast-paced, dynamic work environment.
Strong organizational and project management abilities.
Attention to detail and a commitment to accuracy.
Capability to work independently as well as collaboratively within a team.
