Regulatory Affairs Specialist Job at Sun Bum, Encinitas, CA

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  • Sun Bum
  • Encinitas, CA

Job Description

US:

In 2010, we started making sun care products to protect ourselves, our families and our friends from the damaging rays of the sun. Since then, we’ve grown and expanded into hair care and lip care products, and even launched Baby Bum, our rad plant-based baby skin care line. Along the way, we’ve been building an amazing, like-minded global community of friends that encourage us and help us be better. Today, we are looking for a few more talented and passionate people to join our crew – not for the money or the awesome location to live and work, but for the opportunity to change the world a little with us.

Summary:

The Regulatory Affairs Specialist is responsible for regulatory affairs activities related to Sun Bum, LLC submissions and compliance obligations. The Regulatory Affairs Specialist, with oversight, will compile necessary documentation for regulatory submissions (FDA/TGA/Canada/EU) and provide regulatory agencies with information required for product marketing and distribution. The role will provide compliance related guidance and implementation to Sun Bum, LLC .

Essential Duties and Responsibilities:

  • With oversight, helps prepare and submit regulatory applications and registrations for the US FDA and retail outlets including but not limited to CDER, MOCRA, WERCS, and PURVIEW.
  • Registers products for premarket approval for all international markets including but not limited to Australia, Canada, EU, LATAM and GCC.
  • Registers and notifies products through all State regulations such as California safe cosmetics, Washington state and New Jersey packaging requirements, and CARB.
  • Helps review and maintain raw material information in current software system for all new and reformulated products.
  • Updates data for marketing certifications such as Vegetarian Society and Skin Cancer Foundation.
  • Helps create and maintain all Safety Data Sheets.
  • Keep Master Dossier up to date with all regulatory related records.
  • Adhere to and support Sun Bum LLC’s Corporate Policies and Procedures.

Required Skills / Experience / Competencies:

  • Bachelor’s degree in a science related field (Biology, Chemistry or equivalent)
  • 1-3 years’ regulatory experience in the personal care industry.
  • OTC experience a plus.

Preferred Skills / Experience / Competencies:

  • Excellent analytical and problem-solving skills
  • Excellent communication and organizational skills
  • Excellent numerical skills and understanding of data analysis/statistical methods
  • Good knowledge of MS Office and databases (Coptis and/or ASANA a plus)
  • Great attention to detail and a result driven approach
  • Reliable and Trustworthy

Compensation & Job Requirements:

  • $63,520 - $83,370 is the salary range for this position. It represents a portion of the overall package, and includes flexibility based on the candidate's qualifications.
  • Full Time
  • Up to 5% overnight travel

Other duties, responsibilities and activities may change or be assigned

at any time with or without notice as assigned by the Manager. The job description

does not constitute a contract of employment and the position remains at-will.

Disclaimer: Please note, if you are selected to have a chat with us, you will receive an email from a @sunbum.com domain. Anyone else is an imposter. Lame. Be aware of phishing emails/text messages. Sun Bum will never text or WhatsApp you about your candidacy or ask for personal, confidential information beyond what’s typically required for a job application. Double lame.

Job Tags

Full time, Contract work, Gangs, Night shift,

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