Associate Director of Regulatory Affairs and Global Labeling - Pharmaceuticals

Confidential Company  •  Berkeley, CA

8 - 10 years experience  •  Insurance

$150K - $250K
Posted on 10/05/17 by Branden Lynch
Confidential Company
Berkeley, CA
8 - 10 years experience
$150K - $250K
Posted on 10/05/17 Branden Lynch

Well established industry leader seeks an Associate Director of Regulatory Affairs and Global Labeling to develop and implement regulatory labeling strategy and documentation for products in development. 


The Job: 


*** Lead development, review, approval, and implementation process for Core Data Sheets (CDSs), US Package Inserts (PIs), Summary of Product Characteristics (SmPCs), and similar labeling documents. 


*** Serve as subject matter expert for key labeling requirements and regulations. 


*** Review and approve labels, patient leaflets, cartons, and similar labeling documents. 


*** Develop processes to review and approve CDS and country-specific labeling, tracking of CDS updates as part of the signal detection and management process, implementation of CDS in country-specific labeling, and archiving of labeling. 


Experience Sought: 


***Bachelors in Health or Life Sciences related field. 


***8+ years of Global Labeling experience in Pharmaceutical, Biotechnology, or similar field. 


Scientific leadership role offers a competitive compensation package commensurate with experience, bonuses, full medical benefits, 401(k) savings plan, stock options, health and wellness benefits, generous paid vacation time, numerous professional development opportunities, and more! 


Please reference #37274218 when responding.Education Requirements: Bachelor DegreeMinimum Experience Requirements: 5-10 yearsJob City Location: BerkeleyJob State Location: CAJob Country Location: USASalary Range: $150,000 to $250,000

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: Top 10 Job Site Top 10 Careers Site Director of Global Labeling Global Regulatory Function Label Processing Pharmaceutical Products Regulatory Affairs FDA Quality Assurance Specification Specialist Regulatory and Product Administration Manager Labeling Claims Manager


DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.

 If you submit an application or resume which contains your email address, we will use that email address to communicate with you about this and other positions. We use an email quality control service to maintain security and a remove and dead address filter. 

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