Opportunity for an experienced Regulatory Document Specialist to join an up-and-coming pharmaceutical company with multiple products in a strong pipeline and solid financial partnerships with global companies on several leading product candidates.

Requires:

*** Experience supporting or managing the development, compilation, formatting, review, and uploading of Submissions (INDs, NDAs, BLAs, ANDAs, Master Files) in proper eCTD format.

*** Hands-on expertise ensuring eCTD submissions meet FDA standards and regulatory guidelines for technical components including: High level folder structure; XML backbone file; Lower level folder structure; Document type definitions (DTDs); Stylesheets, etc.

*** Experience identifying outdated processes or standards and developing new SOPs.

*** Experience training team members.

*** Bachelors Degree and experience in a Regulatory Operations eCTD submissions role.

About:

*** Excellent growth opportunity with internal promotions and hands-on mentorship from upper management.

*** Competitive salary designed around attracting the top individual and competitive bonus packages for total compensation upwards of $145,000.

*** Great company benefits package including full-family coverage for: doctor visits, specialist visits, dental care (including emergencies), prescription eyewear and contact plans, and more.

*** Employee focused work schedule with flexible PTO (paid time off) for personal days, sick days, and vacation weeks in addition to 10 paid holidays off.

*** Equity package including employee stock options, matched 401(k) contribution, tuition reimbursement, 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:
1000024785_10007337@jobbank302.com

Please reference #36988239 when responding.

2+ years

California

$125,000.00

$145,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024785_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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