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Director - Clinical Phase Regulatory Submission Strategist - San Jose, CA
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Description
Seeking experience leading submission of INDs, NDAs, ANDAs, BLAs, Master Files, etc. formatted according to FDA eCTD requirements.
Shall:
*** Lead regulatory submission planning, formatting, publishing, transmitting and archiving in both paper and electronic format.
*** Manage development of processes, templates, standards, and guide sheets.
*** Guide and train Regulatory Operations personnel.
*** Oversee applications and systems support and systems training programs.
*** Support development projects within Regulatory Affairs.
*** Interact with Regulatory Affairs and departments providing information to be submitted.
Requires:
*** Expertise with publishing tools such as InSight, ISIPublisher, eCTDXPress, etc.
*** Expert knowledge of FDA requirements governing electronic submissions.
Be a critical part of a growing company exploring new avenues in drug development with strong financial partnerships in leading global companies. Opportunity includes long-term career growth with internal promotion, upwards mobility, company paid training, direct interactions with upper management, and ability to positively impact the company from day 1. Competitive compensation package designed around top talent with six figure + salary and annual bonus package along with company stock ownership, exceptional benefits package, 401(k) with competitive company matching, and more!
For details contact Branden F. Lynch at:
(609) 584-9000 ext 241
Or submit resume online at:
http://dmc9.com/bfl/app.asp
Or email to:
1000025597_10007335@jobbank301.com
Please reference #36988441 when responding.
Years of Experience
2+ years
Location
California
Low Salary
$125,000.00
High Salary
$145,000.00
Job Contact
Branden F. Lynch
Job Contact Phone
(609) 584-9000 ext 241
Job Contact Email
1000025597_10007335@jobbank301.com
Apply Online
http://dmc9.com/bfl/app.asp
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Zip
Legal Notices
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 Regulatory Affairs Regulatory Operations Dossier Specialist Document Submission eCTD Electronic Common Technical Document Specialist Submissions Manager FDA IND Investigational New Drug Application NDA New Drug Application BLA Biologic License Application MAA Marketing Authorization Application CTA Clinical Trial Authorization NDS New Drug Submission Electronic Publishing Specialist eCTDXPress GS Publish GlobalSubmit Publish OmniSuite Omnicia DIA Drug Information Association RAPS Regulatory Affairs Professional Society Extedo Stem Cell Regenerative Medicine
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. To cancel receiving email communications, simply send an email from your address with the word "remove" in the subject line to pleaseremove@candseek4.com Or, visit the website at www.jobbankremove.com. If you have further concern regarding email received from us, call (609) 584-5499.
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