Assistant Regulatory Manager - Freelancer

Leading manufacturer and distributor of beauty and personal care products seeks a Regulatory Manager. We are looking for someone with a background in packaging to join our regulatory team focusing on packing and materials. Must have experience in plastics.

Job description:

You will play a key role in overall product compliance as it applies to domestic and international markets. The ideal candidate must have the ability to stay knowledgeable & current with industry regulations and how to integrate them into the current business model. You will coordinate regulatory documents, ensuring that submissions are timely and regulatory objectives are met. Research scientific and regulatory information to write, edit, and review reports.

Key Duties and Responsibilities:

· Prepares international regulatory submissions, progress reports, supplements and amendments, license renewal and annual registrations.

· Obtains Certificates of Product for Export or other applicable export notifications from the FDA as needed.

· Keeps abreast of changes and proposed changes to the worldwide regulatory requirements related to products and processes.

· Coordinates, compiles, and provides submission documents for global regulatory filings, utilizing good understanding of global regulations for cosmetic products.

· Organizes and maintains regulatory files with records required to meet federal and international guidelines

· Develops and maintains regulatory library containing company specific documents, reference articles, etc., as well as on-site archived regulatory submissions documents.

· Ensures complete customer satisfaction with all company products within assigned territory.

· Advises the registration team on how to place products into certain markets, answer questions regarding product registration, and justify product ingredients.

· Creates Quality documentation: C of A, stability, specification, as well as assisting quality with interpreting test results.

· Experience in collecting, writing, revising, and converting MSDS (material safety data sheets) to SDS (safety data sheets) highly preferred.

· Familiarity with handling CARB (California Air Resources Board) Survey.

· Create and review regulatory documentation including, but not limited to, ingredient listing, quantitative and qualitative documentation, & label claim review.

· Other duties as required.

Education/Experience Necessary:

Bachelor’s degree in chemistry, Life Science, Engineering, or related discipline preferred. Senior Specialist level.
Minimum 4 - 5 years of experience within Quality or Regulatory, Quality, or Product Development in cosmetic/pharmaceutical manufacturing highly preferred.
Associate level: 3 -5 years of Regulatory experience.
Working knowledge of cosmetic regulatory requirements in domestic and international markets.
Extended Producer Responsibility (EPR) knowledge is a plus. Responsible for ensuring a company's compliance with EPR regulations by managing registration, reporting, and compliance activities. Duties include interpreting new and existing EPR legislation, collaborating with internal teams like finance and product development to adapt strategies, and managing relationships with external stakeholders such as regulatory bodies and Producer Responsibility Organizations (PROs).
General understanding of overall manufacturing and quality processes.
Excellent verbal and written communication skills.
Superior organizational skills
Strict attention to detail and follow-through
Ability to work independently
Ability to multi-task
Experience in the preparation and regulatory submissions is an asset
Knowledge of DOT/IATA/IMDG and experience with CARB/VOC/EPA preferred.
Excellent computer skills including Microsoft Office applications
Working knowledge of EU Cosmetic Regulation 1223/2009