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1+ months

Regulatory Affairs Labeling Lead

Kelly Services
Bridgewater, NJ 08807
**Regulatory Affairs Labeling Lead**


Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a with our client, a leader **Regulatory Affairs Labeling Lead** in a leading pharmaceutical company, located in **Bridgewater, NJ.**


REMOTE option!


2 year assignment!


**Responsibilities:**


+ Labeling Lead is responsible for leading labeling artwork projects for Pharma and Consumer products.

+ Manages labeling artwork projects for updates to existing product labeling components including package inserts, medication guides, patient/pharmacist information inserts, directions for use, instructions for use, container labels, and cartons, etc. required for company name change

+ Evaluates content of labeling on all labeling component artwork to ensure compliance with regulatory requirements and company guidelines Branding, Trademarks Collaborates and facilitates review and approval processes with appropriate cross-functional teams such as Regulatory Affairs Product Lead, CMC, Graphics, Legal, Quality, Supply Chain, Marketing, R D, Engineering and external parties to develop new or update existing labeling component artwork


**TECHNICAL COMPETENCIES:**


+ Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations. Knowledge of FDA regulations relating to submissions and regulatory approval of drug products.

+ Knowledge of pharmaceutical industry product labeling processes for review and obtaining regulatory approvals. Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.

+ Ability to critically and efficiently review detailed information to support a labeling revision.

+ Strong technical knowledge of drug listing and SPL.

+ Demonstrated ability in analytical reasoning and critical thinking skills

+ Ability contribute and lead a team environment Ability to understand and apply business drivers outside of Regulatory Affairs Strong communication skills; both oral and written Strong interpersonal skills with the ability to influence others in a positive and effective manner

+ Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies able to do so quickly without sacrificing attention to detail 8+ years relevant pharmaceutical industry and regulatory experience, 4 + years experience within pharmaceutical labeling,

+ Bachelor s degree or higher,

+ Applied knowledge of FDA labeling requirements,

+ Familiarity with XML concepts including structured product labels SPLs preferred.


**Important information** : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-24 Expires: 2021-11-04

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Regulatory Affairs Labeling Lead

Kelly Services
Bridgewater, NJ 08807

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