Director of Regulatory Affairs - Regenerative Medicine

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POST DATE 8/9/2016
END DATE 12/19/2016

Diedre Moire Corporation, Inc San Jose, CA

San Jose, CA
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Full Time
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Seeking Regulatory Affairs leadership with a background in Regenerative Medicine to lead the development of strategies and objectives for the global regulatory affairs group in a growing pharmaceutical company with an exciting pipeline!

Requires experience with the following:

*** Developing regulatory policies, objectives, and strategies development and marketing of therapeutics, medical device products, or similar.

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

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

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

Interact with internal and external executives and stakeholders to lead projects. Full family benefits package (medical, dental, vision, prescription, life, disability, etc.) and flexible spending account, PTO, vacation, generous base salary, annual bonuses, equity stock options, long term incentives, signing bonus with relocation assistance for remote individuals, matched 401(k) pension plan contribution, and more.

Please reference #36931108 when responding.

Education Requirements: Doctorate degree
Minimum Experience Requirements: 10-15 years
Job City Location: San Jose
Job State Location: CA
Job Country Location: USA
Salary Range: $200,000 to $250,000

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.

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