Regulatory Affairs Specialist at Polysciences, Inc. in Newtown, Pennsylvania

Job Description:

Dionis®, the leading goat milk brand in the U.S, is a woman founded and operated brand built on the power of goat milk. We believe this magical ingredient is not only good for your body but is also great for your skin. We focus on nourishing our body from inside out, empowering everyone to love the way they look and feel in their skin. We are sold domestically, internationally, and directly through our site dionisgmskincare.com.

We are seeking a product Regulatory Specialist responsible for the safety evaluation and documentation of raw materials and finished formulations for Dionis Goat Milk Skincare in compliance with global regulations and guidelines.  This is a technical position that will require in-depth working knowledge of toxicology and safety risk assessment, experience in problem solving, and execution of tasks related to approval of raw materials and finished formulas developed prior to market launch.  The position supports the Research and Development department and works cross functionally with Sales and Operations ensuring company compliance with local, state and federal and international regulations associated with manufacturing and marketing hair-care, personal care, skincare and OTC (Over the counter) products.  Our qualified candidate will assess new/upcoming regulations impacting Dionis, provide appropriate risk assessments, evaluate their impact, and make recommendations.

Responsibilities and Essential Duties:

• Conduct robust product safety and compliance assessments ensuring they meet global regulations on raw materials and finish formulations and testing for each category of product.


• Evaluate ingredients and raw materials and formulations based on risk assessments conducted and provide safety approvals.


• Maintain PIF for each product in catalog and newly launched.


• Compile, catalog, and archive documentation to support regulatory requirements.


• Compile and submit new formulas for regulatory filing with the FDA and other regulatory bodies.


• Interface and collaborate with appropriate R&D team to support global compliance assessment of new raw materials and formulas.


• Prepare and submit products submissions or registrations for all product categories globally and domestically (OTC and Non-OTC)


• Ensure products placed on the market comply with local, county, and/or federal regulations.


• Proactively monitor changes in the regulatory environment and provide insight and recommendations on how to address them appropriately.


• Work collaboratively with R&D, Sales, and Operations to evaluate risks and provide risk assessments to the key stakeholders.

Technical Skills Required

• Relevant regulatory affairs expertise in the cosmetic, OTC, or consumer/personal health care industries.


• Demonstrated experience in the preparation and submission of regulatory documents.


• Excellent verbal and written communication skills


• Solid organizational skills.


• Ability to work independently.


• Ability to work in a fast-paced high matrixed environment while meeting established deadlines.

Experience Required

• BS in Regulatory Affairs


• 5+ Years of experience in cosmetics or personal care industry.


• Thoroughly familiar with global regulations for cosmetics and OTC products.


• Must have a strong understanding and knowledge of US and international cosmetic regulations/US Food & Drug Administration (FDA)/US Federal Food Drug and Cosmetic Act/US State Regulations pertaining to the compliance of and safety of practices and cosmetic and OTS products.


• Demonstrated skills in analyzing, reporting, documenting information with attention to detail.


• Knowledge of quality, CGMP, FDA and OSHA regulations.


• Proficient in Microsoft Excel

What We Offer:

Culture

• Great people


• Peer to Peer Recognition


• Broader, hands-on work experience


• Fun company events


• Competitive Wages & Generous Year-end Bonus

Comprehensive Benefits

• 3 Medical PPO Medical Plans with Telemedicine, Rx, & Vision


• 2 Dental Plans


• Healthcare, Dependent care, & Commuter Flexible Spending Accounts


• 401(k) with company match


• Financial Health & Wellness w/1:1 Coaching


• Basic & Supplemental Life Insurance


• Accident, Hospital Indemnity, & Critical Illness


• Paid Time Off


• Paid Parental Leave


• Short & Long-term Disability


• 9 Paid Holidays

Must have legal authorization to work in the US and will not require sponsorship.

Dionis is an equal opportunity employer. Drug-free workplace. Tobacco-free work site.

Dionis does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit and business need.

Equal access to programs, services, and employment is available to all persons. Those applicants requiring reasonable accommodation to the application process and/or interview process should notify a representative of the Human Resources Department

Find us here Dionis