Apothecary Products (APL) is currently seeking a Regulatory Affairs Associate to grow our R&QA team. In this role, you will be accountable for the timely execution of regulatory plans and associated tasks for products the company offers. You will research regulatory requirements and assist in ensuring regulatory systems are maintained to support existing and new products. Your work will be within a broad spectrum of consumer products including OTC drug, medical devices, dietary supplements, and food.
In this role the incumbent will:
Research regulatory requirements and aid with cost-effective implementation.
Assist in ensuring all domestic and international regulatory affairs activities are compliant with ISO 13485, European Directives and Regulations, US FDA regulations, and GMP requirements, among others.
Assist in the creation and maintenance of clinical evaluations, technical files, risk management files, biological safety assessments, labeling, and other technical information.
Aid in the review of artwork to ensure that specific product or performance claims meet regulatory requirements
Work alongside cross-functional teams to deliver quality and compliant products in a variety of categories such as OTC drug, consumer products, medical devices, dietary supplements, and food.
The Company - Why APL:
APL is a leading innovator, manufacturer, marketer and supplier of simple self-care solutions, pharmacy supplies and wellness aids. We are based in Burnsville, MN with several manufacturing and vendor partners in the US and internationally. APL has pioneered many strong consumer product categories, including medication management. We have many trusted brands in the marketplace and do business with well-known mass retailers, grocery and chain drug stores. We've also got a great culture embedded in our WE CAREvalues that helps ensure we have a lot of fun each day and are a high-performing work team.
The Rewards - What We Offer:
The rewards we provide recognize and retain collaborative, results-oriented, strong contributors. Our comprehensive programs support team members and their families in their efforts to live healthy lives. We strive to create opportunities for career growth and financial success – all while being an agile employer committed to open communication. Rewards include:
Annual incentiveprogram, discounts on products and employee assistance programs
Team member + family insurance programs including employer contributions: Medical, Dental, Life and AD&D, Short-term and Long-term Disability
Vision, Pet, Legal, and Identity Theft insurance programs
Financial wellness benefits including: Health Savings Account, Dependent Care Savings Account, and 401k
Work/life blend: 9 company-paid holidays, Paid Time Off starting at 3 weeks, Paid Volunteer Time, and summer hours
Onsite wellness activities: onsite community garden, Yoga, Volleyball, and walking clubs
Community giveback opportunities supporting local and national charities
Relaxed work environment: casual dress every day of the week, food trucks and many team activities!
EOE/M/F/Vet/Disability. No agency calls at this time.
We seek applicants with these critical skills and experience:
Bachelor’s Degree in Life Sciences.
0-1 year experience in a regulatory-related position; consideration given to applicable internship in related field.
Working knowledge of domestic and international regulatory compliance requirements (e.g. product registration, technical files) and procedures.
Ability to analytically assimilate regulatory information and effectively translate these into practical approaches.
Excellent interpersonal and communication skills including verbal, written and presentation skills.
Internal Number: 2019-1067
About Apothecary Products, LLC
Founded in 1975, Apothecary Products is a global leader in consumer wellness products. Our retail products help consumers improve their health and wellness. We also support pharmacists and the patients they serve with our innovative pharmacy products.
Apothecary Products’ retail brands, Ezy Dose®, Flents®, Protechs® and Wipe ‘N Clear® are market leaders in medication management, pharmacy supply and eye, ear and injury care.
Since innovation is at the core of our business, we take pride in developing products that solve consumer needs and have secured over 70 patents. We are proud that the Arthritis Foundation endorses many of our Ezy Dose medication management products for their easy-to-open features.
Apothecary Products is a worldwide partner with the majority of US retailers (food, drug, mass, club), independent pharmacies and drug wholesalers. We have an international presence in over 80 countries.
Acquired by Norwest Equity Partners in 2014, Apothecary Products is poised to grow its leadership position by offering the best in branded consumer products and pharmacy supplies to all major classes of trade.