A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
Obagi Cosmeceuticals is an industry leading dermo-cosmetic brand that provides transformational skin care products, with a 35+ year legacy backed by science and innovation to protect and enhance skin tone and texture. Obagi is widely recognized by US dermatologists and plastic surgeons for its clinical excellence and science-backed approach, remaining a leader in the beauty space and operates as an innovative, global, omni-channel luxury consumer products business with sales distribution to physicians, wholesale partners, retail outlets, Amazon, and direct-to-consumer (DTC) channels. On a mission to create a global, best-in-class multi-brand, multicategory portfolio, Obagi will continue to redefine the future of skincare. We are Obagi. Fearless. Together.
What We Need:
Obagi is seeking a reliable and meticulous Regulatory Affairs Associate to help the Regulatory team ensure global compliance across its collection of skincare products. This individual will help organize, manage, and maintain files across our databases and platforms, along with ensuring that all files adhere to regulatory and compliance requirements across the jurisdictions where our operations extend.
What You'll Do:
Reviewing ingredients for regulatory compliance for different markets and product categories. Partner with manufacturers and ingredient suppliers to acquire all necessary documentation to maintain an accurate library of robust products and raw materials. Prepare, compile, and organize all relevant documentation for product registrations and listings. Ensure renewals for state licenses. Maintain business systems, databases, and knowledge sharing systems as appropriate. Coordinate FDA Drug Listing submissions for Rx and OTC products under supervision from Regulatory Leadership Ensure appropriate follow-up correspondence, such as re-submissions, re-certifications, renewals as required. Other duties as assigned by the Supervisor.
What You'll Need:
A bachelor's degree from an accredited university is required. A focus in Life Sciences or Chemistry is highly preferred. At least 3-4+ years of relevant experience within regulatory affairs; familiarity with regulatory frameworks across various jurisdictions and a keen ability to accurately interpret and apply them real time. Exceptional organizational and prioritization/time management skills; demonstrated ability to work under pressure to meet deadlines. Comfortable operating in a fast paced, ever-changing environment; someone who thrives in ambiguity and adapts quickly. Proficiency in Microsoft Office and other technologies. An energetic, positive attitude that encourages a team and supports the growth and professional development of others.
Physical Requirements:
These demands document the physical requirements of a specific job.
Criteria may include:
Lifting, Carrying, Push/Pull, Sitting/Standing (In Place); On Feet, Walking, Bending, Turn/Twist; Kneeling; Squatting; Crawling; Climbing; Reaching (Out)/Reaching (Up), Grasping, Wrist Turning; Pinching; Finger Manipulation, Hearing, Talking, Working with a computer for eight hours, Working in close quarters. Communicating over the telephone for eight hours.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of job requirements, so classified. All employees may be required to perform duties outside of their normal responsibilities, from time to time, as needed. gmhUv77nGq
