Director of Regulatory Affairs - Regenerative Medicine 8/9/2016
Diedre Moire Corporation, Inc
San Jose, CA
JOB DESCRIPTIONAPPLY 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.
Top 10 Job Site Top 10 Careers Site Regulatory Affairs Director Senior Director Regulatory Affairs Regenerative Medicine Global Regulatory Affairs Biotechnology Stem Cells AMD Age Related Macular Degeneration Ocular Disease Cell Based Therapies Clinical Trial Tissue Engineering Cell Therapy Biomaterials Orthopedic Ophthalmology FDA EMA European Medicines Agency
DISCLAIMER: We will make every effort to consider applications for all available positions and shall use one or more of the contact methods and addresses indicated in resume or online application. Indicated location may be proximate or may be desirable point of embarkation for paid or unpaid relocation to another venue. Job descriptions may fit single or multiple presently available or anticipated positions and are NOT an offer of employment or contract implied or otherwise. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers. Linguistics used herein may use First Person Singular and First Person Plural grammatical person construction for and with the meaning of Third Person Singular and Third Person Plural references. We reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Response to a specific posting or advertisement may result in consideration for other opportunities and not necessarily the incentive or basis of the response. Nothing herein is or may be considered a promise, guarantee, offer, pledge, agreement, contract, or oath.