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Senior Regulatory Specialist


This is a Contract position in Anaheim, CA posted June 13, 2022.

(External) What You Need: Bachelor’s degree in Chemistry or related regulatory coursework.Commitment to model and live out on company Core Values (Accountability, Community, Innovation and Courage) and a positive mindset are critical for success and should reflect in everything you doChemistry knowledge; understanding of chemicals and Quality background a plusRegulatory knowledge of domestic and international cosmetic & topical OTC drug applicationsExperience in the personal care industry from 5 to 7 years a plusFunctional/Technical Knowledge, Skills and Abilities Required: Technical writing skills; high accuracy on document preparation and reviewProficient computer skills (Excel, Word, adaptable to government and internal software programs)Detail oriented, able to work with intricate spreadsheets and data collectionHigh level observation skills, quick learnerExcellent communication skills, both oral and written Ability to multi-task and still able to set priorities.Attention to details, work with less supervision, and able to keep up with deadlines.

(External) What You’ll Be Doing: Prepare regulatory reviews of product formulations.

Reviews include evaluating chemicals for safety and regulatory compliance with U.S.

and international regulations.Prepare and update domestic and/or international ingredient listings as needed.Review label, claims and marketing collateral and approval as needed.Author GHS compliant safety data sheets.Enter regulatory and safety information of raw materials into software.Review and approve raw material/alternate sourcing qualifications assigned to his/her own brand.Prepare drug listings for OTC drug products for FDA structured product labeling (electronic submissions required by FDA).

Prepare product notification or pre-market approval submissions in other markets for line extensions and new product releases.

These requirements may include current markets such as Canada, Australia, New Zealand, European Union and beyondPrepare product technical information files for toxicological review and safety assessments as needed.FDA VCRP reporting as needed; CARB surveys as needed; CA Safe Cosmetics Act reporting as needed.Create and implement strategies with Sr.

Manager or with multifunctional teams for international regulatory submissions.Support each affiliate/distributor on a case-by-case basis to address product registrations, custom requirements, and negotiations with ministries of health in each respective country
· Development and implementation of procedures for Domestic and International Regulatory Affairs.Responsible for the periodic file maintenance of product registrations, submissions, manufacturer information and GMP status related to Personal Skin Care (cosmetics / drugs).Prepares and submits periodic reports, as required and performs special tasks and assignments, as required.Provide on-going support to all levels of Team Members, not limited to Research and Development, Product Development, Quality, and/or Marketing to facilitate required projects.Responsible for raising awareness of our commitment to Corporate Social Responsibility and should actively participate in activities and initiatives which are designed to have a positive impact on the environment and local communities.As an employee of a purpose driven company establish a goal relative to social and environmental impact.

(External) Why You’re Here: The position of the Sr.

Regulatory Affairs Specialist in Personal Care reports to the Sr.

Manager and will work closely with Product Development and Marketing.

This position will entail ensuring the compliance of personal care products in the countries that Arbonne does business in.

These will include performing formula assessments and ingredient listings.

It will also include the review of labels, claims, marketing collaterals and substantiation, and be knowledgeable in the preparation of submissions (notifications & registrations) for new products, product changes, as required to ensure continued compliance, and timely approval for market release of products.

Assist the personal care team and management by giving updates and assessments on current and emerging regulations.

Respond to raised questions quickly and be knowledgeable of all the appropriate points and basics of the subject matter in question.