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Regulatory Affairs Associate
Ref No.: 19-12074
Location: Irvine, California
Sunrise System Inc. is currently looking for Regulatory Affairs Associate in Irvine, CA with one of our top client.
 
Job Title: Regulatory Affairs Associate
Job Id: 19-12074
Location: Irvine, CA 92612
Duration: 6 months
Position Type: Hourly contract Position (W2 only)
 
Position Description
  • The Sr. Regulatory Affairs Analyst supports the development and implementation of the global regulatory strategy for SkinMedica skin care products.
  • With supervision, the analyst researches and interprets health authority regulations/guidance and provides regulatory affairs information to project teams, as appropriate.
  • Supports management with implementation of departmental strategies and policies.
  • Supports special projects including review of chat engagements on Client-supported website forums.
Main Areas of Responsibilities
  • Reviews SkinMedica.com chat engagements for compliance and adherence to regulatory requirements
  • Reviews new 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.
  • Reviews advertising and promotional pieces for accuracy and for other legal/regulatory requirements and communicates planned/approved changes with other functions, including but not limited to medical affairs and commercial teams.
  • Supports ad hoc regulatory activities as required.
  • Provides regulatory guidance regarding advertising and promotional material, new campaigns and launch strategies.
  • Generates ingredient list (IL), Quantitative & Qualitative (Q&Q), and Cosmetic or OTC formulation assessments.
  • Reviews and approves all new formulations/labeling for local and global compliance
  • Monitors competitor advertising to keep abreast of market promotional and advertising strategies.
  • Provides status updates to management
  • Notifies relevant cross functional team members of regulatory activities, as appropriate
Requirements
  • The following listed requirements need to be met at a minimum level to be considered for the job:
  • 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.
  • 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.
About Client
  • Sr Regulatory Affairs Analyst – Special Project – SkinMedica.com Chat Reviews
    Client is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.
  • Client is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
  • Client markets a portfolio of best-in-class products that provide Client treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories.
  • With commercial operations in approximately 100 countries, Client is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
  • Our success is powered by our world-class team's commitment to being Bold for Life.
  • Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Contact
Rahul
Direct: (732) 272 0347| Email: Rahul.R@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com