Regulatory Affairs Specialist

1 week ago

Irvine, United States Rangam Full time

Position Title: Regulatory Affairs Specialist - Skincare


Length of Contract: 12 months


Location/Site: Irvine - Hybrid


What are the top 3-5 skills, experience or education required for this position:

  • Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.
  • Ability to manage multiple priorities and projects with strict deadlines
  • Detail-oriented with the ability to proofread and check documents for accuracy and consistency.
  • Excellent communication skills


Purpose Statement:

  • The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for Skin Medica products.
  • With supervision, the specialist reviews, plans and prepares regulatory documents and labelling for cosmetic or OTC product registrations/updates.
  • With supervision, the specialist researches and interprets health authority regulations/guidance and provides regulatory information to cross-functional teams, as appropriate.


Major Responsibilities:

  • Reviews product labeling for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to operations, medical affairs and commercial teams.
  • Provides regulatory guidance to other departments as needed to ensure compliance with regulations.
  • Conducts regulatory assessments of product changes, labeling revision, and new product introduction.
  • Generates ingredient list (IL), Quantitative & Qualitative (Q&Q), and Cosmetic or OTC formulation assessments.
  • Reviews and approves formulations and labeling for local and global compliance.
  • Generates Origin, Animal testing, Client, CMR/Nano, Gluten Free, BSE and other requested statements upon review of formula or ingredients.
  • Acquires necessary regulatory documentation from Raw Material suppliers.
  • Provides insight to formulators to create global and local compliant formulations.
  • Prepares and submits regulatory documents for cosmetic registration and responds to other regulatory questions as needed.
  • Ensures archiving of activities, especially submissions, internal memos and key correspondence.
  • Monitors and interpret regulatory requirements and guidelines and assesses impact on SkinMedica products.
  • Notifies relevant cross-functional team members of regulatory activities, as appropriate.
  • Provides status updates to management.


Qualifications:

  • Basic knowledge of personal care product industry regulatory affairs discipline throughout the product lifecycle including development, commercialization and operations.
  • Ability to critically and effectively review detailed information to support a labelling revision including all applicable regulations.
  • Ability to manage multiple priorities and projects with strict deadlines
  • Working knowledge of the OTC drug monographs and cosmetics.
  • Detail-oriented with the ability to proofread and check documents for accuracy and consistency.
  • Excellent communication skills.
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner.
  • Ability to understand and apply business drivers outside of Regulatory Affairs.


Education

  • BS degree in a scientific field, plus two years’ experience in regulatory affairs; or equivalent relevant work experience.
  • MS degree in a scientific field, plus one year experience in regulatory affairs; or equivalent relevant work experience.
  • PhD degree in a scientific field, with no experience in regulatory affairs.

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