Regulatory Affairs Associate Skincare

Regulatory Affairs Associate I – Skincare

Position Details:
Client Industry: Pharmaceutical/Medical Device/Biotechnology

Title:

Regulatory Affairs Associate I – Skincare

Location:

Irvine, CA 92612 – Hybrid Duration: 12-month Contract Shift: USA Standard Business Hours Shift Pay Rate: $34.00 – $38.00 per hour

Job Description:

The Regulatory Affairs Associate I 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.
• Review international regulations to assess and support market expansion feasibility.
• Monitor and track federal, state, and international regulatory developments relevant to the organization's business and operations.
• Generates ingredient list (IL) 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 Skin Medica 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.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually – These all are subject to applicable eligibility).