Director of Regulatory Labeling - Pharmaceutical Products

Confidential Company  •  San Rafael, CA

5 - 7 years experience  •  Insurance

$150K - $250K
Posted on 10/05/17 by Branden Lynch
Confidential Company
San Rafael, CA
5 - 7 years experience
$150K - $250K
Posted on 10/05/17 Branden Lynch

Biotechnology industry leader seeks a Director of Regulatory Labeling to oversee Regulatory Affairs and Pharmacovigilance functions. Candidate will define and execute regulatory strategy and pharmacovigilance requirements for products both on the market and in development. 




*** Identify requirements to ensure regulatory compliance of labeling claims. Provide regulatory strategic guidance to and oversight of global labeling activities for products in endocrinology, oncology, neurology, metabolism, and other therapeutic areas. 


*** Assess country-specific deviations from the Core Company Data Sheet and ensure local requirements are met and translations properly executed. 


*** Create and maintain regulatory compliant, competitive, and up to date Company Core Data Sheets for assigned key development projects and marketed products. 


*** Prepare labeling negotiation strategic plans and participate in label related Health Authority negotiations. 


*** Review final artwork to be implemented into production. Approve all change requests for revised labeling for assigned products. 


*** Guide Supply Chain and QA teams on labeling requirements implementation. 


Experience Sought: 


***Bachelors or Masters. 


*** 6+ years of Labeling, Regulatory Affairs, or similar experience in the Pharmaceutical industry. 


*** Knowledge of International labeling regulations and practices. 


High visibility leadership role comes with an industry 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 #37274205 when responding

.Education Requirements: BachelorDegree

Minimum Experience Requirements: 5-10 years

Job City Location: San Rafael

Job State Location: CA

Job Country Location: USA

Salary Range: $150,000 to $250,000

Diedre Moire Corporation, Inc.

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.

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