Regulatory Affairs Associate

Obagi
Long Beach, CA, US
Full-time

Who We Are :

Obagi Cosmeceuticals is an industry leading, $115M dermo-cosmetic brand that provides transformational skin care products clinically formulated to minimize signs of skin aging, address dark spots, hyperpigmentation, fine lines, and wrinkles.

A 35-year legacy backed by science and innovation to protect and enhance skin tone and texture. Ranked No. 1 and widely recognized by US dermatologists and plastic surgeons for its clinical excellence and science-backed approach, Obagi remains 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 organize, manage, and maintain files in our database / platform.

This person will play a key role in ensuring that all files adhere to regulatory and compliance requirements across the jurisdictions where our operations extend.

This is a short term, contract position through December 2024.

What You’ll Do :

  • Reviewing ingredients for regulatory compliance for different markets and product categories.
  • Provide comprehensive regulatory assessments for ingredients, new products, and reformulations using appropriate databases.
  • 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 and Quality Leadership
  • Initiate change controls in Ensur QMS system as required.
  • Manage purchase orders (POs) for the regulatory department.
  • 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 high school diploma is required; a bachelor’s degree from an accredited university with a focus in Life Sciences; Chemistry highly preferred.
  • At least 2-3+ 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.

CPG / Beauty experience required.

  • 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.

30+ days ago
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