Regulatory Affairs Associate - Hauppauge, United States - American Health Formulations

American Health Formulations

Verified Company

Hauppauge, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job description

The Role
We are looking for an experienced Regulatory Associate to join our Company.

Responsibilities:
_but not limited to:_

Study and search FDA regulatory, policy, guidance, and scientific documents.
Prepare FDA filing (GRAS, NDI, DMF, ANDA, NDA, Medical Devices) required documents.
Formatting and compiling information as per projects required based on regulations.
Ensuring compliance with required regulations for filing.
Keeping up to date with changes in regulatory guidelines.
Review products safety and toxicology related studies and reports, provide suggestions.
Review products explore dosage and how to use statistical software and calculate the EDI.
Ensure all documents quality standards are met with, and submissions are completed on time.
Follow up with regulatory agencies and outside expert panels.
Work with projects team leader and assisting CSO organizing the projects and follow up.
Other office administrative works in general.

Required Technical Skills and Abilities:

Need to be well organized.
Work independently and in teams.
Able to handle tight deadlines.
Able to work in fast paced environment.

Education Qualification and Experience Requirements:

Bachelor's degree in science, preferably in public safety and health field.
Master's degree preferred in toxicology science.
2 to 5 years of experience in regulatory documentation, filing etc.
Chemistry knowledge of Active Pharmaceutical Ingredients, Active Nutraceutical Ingredients, Active Food Ingredients, and Active Flavor Ingredients.
Knowledge of FDA guidelines and regulation for food, dietary, pharmaceutical ingredients and medical devices.

Work Environment:

Work in an office environment but also at very close proximity to heavy machinery in the warehouse and powders from products.
May be in contact with Allergens (Milk, Eggs, Fish, Crustacean Shellfish. Tree Nuts, Peanuts, Wheat, and Soybeans).
Potential to move between office and warehouse areas to complete job functions.

We offer a comprehensive benefit package including medical, dental, vision, and 401K with match.

The Company
American Health Formulations is a fast-growing contract development and manufacturer of Dietary Supplements, Medical Foods, Herbal and OTC Products. We offer end to end services from R&D, custom formulation development, to production, packaging, and in house testing. We are experienced in the Nutraceutical, Pharmaceutical, Food and Beverage, and Cosmetic industries.

Pay:
$45, $50,000.00 per year

Benefits: