Regulatory Affairs Associate

6 days ago

Irvine, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • The Regulatory Affairs Specialist supports the development and implementation of the global regulatory strategy for several 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.

  • 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, Allergens, 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:

  • BS degree in a scientific field, plus two years' experience in regulatory affairs; or equivalent relevant work experience; OR

  • MS degree in a scientific field, plus one year experience in regulatory affairs; or equivalent relevant work experience; OR

  • PhD degree in a scientific field, with no experience in regulatory affairs.

  • 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

  • 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.

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