Seeking experience leading submission of INDs, NDAs, ANDAs, BLAs, Master Files, etc. formatted according to FDA eCTD requirements.

Activities:

*** Work closely with subordinates to compile documents, review hypertext links, ensure PDFs are submission ready, format tables and graphics, bookmark sections, and proof submission according to internal and FDA defined standards.

*** Develop new processes, procedures, and submission activities to improve efficiency and accuracy during submission process.

*** Identify, evaluate, and select new publishing software tools based on current and future submission needs.

*** Work directly with upper management to build and promote the team.

*** Manage submission of eCTD through FDA gateway.

Requires:

*** Direct experience in Regulatory Operations for eCTD 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:
1000024786_10007337@jobbank302.com

Please reference #36988227 when responding.

2+ years

California

$125,000.00

$145,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024786_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 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 Omnicia

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