Opportunity for a 10 year Regulatory Affairs expert to join a biotech company developing restorative therapeutics for neurodegenerative diseases, retinal disorders, cervical spinal cord injuries, and more.

Responsibilities:

*** Develop and implement global regulatory strategies and policies for drug development.

*** Guide regulatory team creating and submitting documents including INDs, NDAs, BLAs, CTAs (Clinical Trial Authorizations), MAAs (Marketing Authorization Applications), IDEs (Investigational Device Exemptions) and PMAs (Premarket Approvals).

*** Lead compliance activities related to patient safety, Patient Risk Management Plans, regulatory audits, and pharmacovigilance activities.

*** Support clinical trials to take products from early stage research through FDA approval.

*** Act as primary regulatory affairs liaison at meetings with internal teams, regulatory agencies, industry partners, etc.

Requirements:

*** Previous responsibility for leading regulatory affairs (RA) activities for multiple therapeutics progressing through varying clinical trial phases.

*** MD or PhD in scientific or life sciences discipline.

Excellent growth opportunities in a leading pharmaceutical company. Interaction with industry leading KOLs and executives with advancement potential into executive leadership. Perquisites include stock options, matched 401(k) and retirement plan. Full company paid medical, dental and health benefits with an industry leading compensation package and generous bonuses. Paid time off from the start, paid vacations and long term incentives.

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:
1000025585_10007337@jobbank302.com

Please reference #36931451 when responding.

10 + years

California

$175,000.00

$225,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000025585_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 Director Head Stem Cell Biology Biologics Medical Devices Regenerative Medicine Stem Cell Stem Cells FDA Food And Drug Administration Pre Market Approval PMA PMAs 510k 510(k) NDA New Drug Application IND Investigational New Drug Application IDE Investigational Device Exemption HDE Humanitarian Device BLA Biologic License Application CTA Clinical Trial Authorization MAA Marketing Authorization Application Exemption Regulations Regulatory Affairs Director In-Vivo Diagnostics IVD Reagents

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