Seeking individual with experience leading Regulatory Affairs efforts for cell therapies, biologic products, tissue engineering products, or other regenerative medicine products.

Shall:

*** Develop, revise, and implement global regulatory strategies and long-term plans for biologic product development and marketing.

*** Act as the key point of contact with external regulatory governing bodies - FDA, other regulatory health agencies, etc.

*** Represent Regulatory Affairs in internal meetings with executive team.

*** Lead preparation and submission of filings including INDs (Investigational New Drug applications), BLAs (Biologic License Applications), NDAs (New Drug Applications), etc.

*** Lead Regulatory Affairs activities during Clinical Trial phases for new products.

*** Initiate internal audits and meet with external representatives during FDA initiated inspections and audits.

Requires:

*** Advanced degree in scientific or life sciences discipline.

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

This is the time to join a growing company with multiple products aimed at treating previously uncurable conditions. As well as the chance to be a critical part of a revolution in medicine, this is a great opportunity to work with a highly trained team of industry experts in a brand new facility with the latest equipment, technology, and capabilities. Fantastic compensation package with generous salary, bonus, stock options, non-monetary incentives (access to exclusive industry events, ability to interact with the highest level of executives in partner organizations, company credit card, etc.), 401(k) with great matching plan, 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:
1000024478_10007337@jobbank302.com

Please reference #36931308 when responding.

10 + years

California

$175,000.00

$225,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000024478_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 RA Director Associate Director Clinical Trials Lead Regenerative Medicine Biologics Cell Therapy Gene Therapy Biologic Product Medical Device Med Device Biotech Biotechnology Pharmaceuticals Biopharm FDA 510k 510(k) NDA New Drug Application IND Investigational New Drug Application IDE Investigational Device Exemption PMA Premarket Approval BLA Biologic License Application CTA Clinical Trial Authorization MAA Marketing Authorization Application Stem Cell

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