Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Irvine, CA 92602
About the Job
Responsibilities:
- Reviews product labelling 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, labelling revision, and new product introduction.
- Generates ingredient list (IL), Quantitative & Qualitative (Q&Q), and Cosmetic or OTC formulation assessments.
- Reviews and approves formulations and labelling 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 assess impact on Skimmed products.
- Notifies relevant cross-functional team members of regulatory activities, as appropriate.
- Provides status updates to management.
- BS degree in a scientific field, plus 2 years' experience in regulatory affairs; or equivalent relevant work experience.
- MS degree in a scientific field, plus 1 year experience in regulatory affairs; or equivalent relevant work experience.
- PhD degree in a scientific field, with no experience in regulatory affairs.
- 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.
Source : Katalyst Healthcares & Life Sciences
