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.

Duties:

*** 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!

For complete details contact Branden Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000028808_10007337@jobbank302.com

Please reference #37274205 when responding.

5+ years

California

$150,000.00

$250,000.00

Branden Lynch

609.584.9000 x241

1000028808_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

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: http://najobbank.com www.najobbank.com 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

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