FDA License / Legality Officer Freelancer

BioKissed Introduction:

BioKissed is an e-commerce retail company, driven by network marketing. We aspire to market sustainable and natural products that may benefit wellbeing, reduce plastic wastes contributing to the climate crises, as well as giving back to the community through charitable projects.

We are currently looking for a passionate and skilled FDA License & Legality Freelancer to join our awesome team in supporting the company's launch.

Job Description:

As the FDA License/Legality Officer Freelancer, you will be a crucial part of our team, supporting the company in the process of FDA Facility Registration, FDA Device Listing, and Documentation/Dossier Preparation & Submission, as well as Follow Up for Medical Devices, Food & Cosmetics.

You will work to ensure compliance with both international and local regulatory standards to obtain licenses as an importer and exporter. Additionally, you will assist in managing GUDID & DUNS/UFI requirements, ensuring our products meet all necessary legal requirements.

Duties and Responsibilities:

• Applying for and renewing the Certificate of Accreditation as an Importer & Exporter, as well as other relevant licenses
• Handling product registration with FDA and other concerned government agencies, including other applications necessary for importing products
• Providing all necessary documents required by the FDA or other government agencies
• Maintaining strict confidentiality of all information and documents related to the licensing process.

Requirements:

• A Bachelor's Degree in a related field is required.
• Minimum three years of relevant work experience.
• Proficient in Microsoft Excel and Word programs.
• Strong communication skills in both Indonesian and English languages.
• Comfortable working independently and as part of a team.
• Effective multitasking, prioritization, and time management skills.
• Excellent written and oral communication.
• Outstanding interpersonal skills.
• Ability to solve problems creatively and innovatively.
• Detailed knowledge of current FDA, ICH, and USP regulations, guidance, and expectations, as well as cGMP regulations, and food and drug law, with the ability to interpret and apply them appropriately.

If you think you're a good fit for this role and would like to join our team, please send us your resume and a cover letter explaining why you're interested in this position and how you can contribute to our mission.