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Sr. Regulatory Affairs Analyst

KORE1 Technologies Irvine, CA
  • Expired: over a month ago. Applications are no longer accepted.



KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for "Sr. Regulatory Affairs Analyst".


Description:

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 KORE1
Specializing in creative and technical recruiting, KORE1 is committed to supporting top IT and Creative professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.


Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.

KORE1 Technologies

Address

Irvine, CA
92612 USA