At Alchemee, we aspire to inspire by creating science-based solutions that are as effective as they are transformative.
Alchemee’s portfolio of brands deliver effective products rooted in introducing wellness options that provide life changing results and empower the world one person at a time.
Our flagship brand, Proactiv, is a leader in treating acne and has helped more than 20 million customers achieve clear skin.
Simply put, at Alchemee our vision is to inspire the world to feel comfortable and powerful in their own skin and our mission is to create science-based solutions that provide better skin for life.
We are looking for forward-thinking individuals who are driven with a customer-first approach.
Individuals who thrive on challenge and are ready to grasp the opportunity of a lifetime.
Because we fundamentally believe every colleague brings unique value to our whole.
We are a workplace where each person feels seen, heard, and valued, and can contribute their unique talent to our collective effort.
The Regulatory Affairs Associate will maintain regulatory processes and procedures to ensure domestic and international regulatory compliance.
This role will work with internal teams to manage the US and global regulatory aspects of new product development and/or lifecycle change control support with ongoing product regulatory maintenance to support the Alchemee product lifecycle requirements.
This position helps define regulatory requirements and will support product development and marketing/brand on science-driven innovative product launches, as well as expansion of the brand.
The Regulatory Affairs Associate guides compliance by following applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems.
Essential Functions Coordinate the preparation of documentation to support regulatory registrations, submissions (product or labeling), amendments, PIF’s or changes to existing registrations, products and/or product renewals.
Collaborate with internal teams including Regulatory, QA/QC, Product Development, Manufacturing, Supply Chain, Marketing, Legal and any other teams to review, create and/or organize regulatory documents in the highest quality and prepare according to priority timelines.
Helps keep organization abreast of regulatory changes (e.g., registration requirements, Prop 65, Clean beauty guidelines), inform teams of applicable changes and implement necessary adjustments to ensure compliance.
Compile preliminary regulatory assessments for all formulas, ingredients and innovations for all countries of interest before formula approval.
Review stability protocols and data, technical procedures, certificates of analysis and other product data to ensure quality and appropriateness to support registration efforts are met.
Work with supervisor to plan, conduct, and manage regulatory activities such as formula reviews, INCI’s, (replacements/equivalency) and regulatory documentation management to meet department and company objectives.
Conduct reviews for all labelling based upon regulatory authority requirements including claims and/or claims substantiation (e.g.
labels, websites, inserts, advertisements, social media and/or brochures, etc.).
Provide Regulatory Affairs support during government, internal and external regulatory audits.
Support US and international regulatory activities by addressing questions and issues that arise as part of the registration process as well as questions pertaining to product reformulations.
Perform other duties as assigned.
Education, Knowledge, Skills, & Abilities Bachelor’s degree in Biology, Chemistry or equivalent relevant experience in lieu of degree, required.
5-7 years of experience working in Regulatory Affairs or Compliance required.
5-7 years of experience working in cosmetics, skin care, OTC/Rx manufacturing industry, required.
Experience developing reports and documents appropriate for state and federal government agencies, required.
Working knowledge in international regulations is a plus.
Excellent organizational, analytical, project management skills, required.
Experience reviewing technical documentation such as certificates of analysis, SDS, compositions statements, test reports or similar documentation, required.
Ability to define, solve problems, collect data, establish facts, and draw valid conclusions.
Proficient in the preparation and formatting of electronic documents utilizing Microsoft Word, Excel, Adobe Acrobat, SPL, ESG Gateway and internal IT systems.
Effective oral and written communication skills, proven ability to create and foster cross-functional partnerships, self-start with a team player approach.
Sincere interest in staying current on all regulatory topics through studying regulations and guidance documents, following trends in regulatory affairs as well as participating in educational opportunities.
Ability to multi-task under fast-paced timelines.
No travel is required.
We are an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.
Note: Please, no external agencies or third parties.