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Regulatory Affairs Specialist - Pharma Advertising And Promotion

Company Name:
Pharthenogene
Seeking individual with experience interfacing directly with officials from the FDA Office of Prescription Drug Promotion (OPDP).
Shall:
Review advertising and marketing materials to ensure submission forms meet regulatory compliance criteria.
Communicate with key decision makers in the Office of Prescription Drug Promotion.
Review and approve all documents and forms including FDA Form-2253 before final submission.
Interface with cross-functional teams including Medical Affairs, Legal, Commercial and Business Development.
Qualifications:
B.S. or M.S. in Health or Life Sciences, Pharm.D. or J.D.
Minimum 5+ years experience in regulatory review and approval for promotional materials in a pharmaceutical company.
Strong knowledge of regulatory submission processes and associated systems.
Join an industry leader as a key contributor to the release of new, high-profile therapeutic solutions. Frequent interaction with FDA members and industry executives. Steady growth opportunities and stable company. Competitive, industry leading salary and executive benefits package and perquisites including stock, matched 401(k), travel reimbursement, pension and retirement plans. Paid time off from start and attractive vacation packages.
For complete details contact Winston F. Reuning at:
(609) 584-9000 ext 230
Or submit resume online at:
Or email to:
Please reference #3609911 when responding
Education Requirements: Master Degree
Minimum Experience Requirements: 5-10 years
Job City Location: Berkeley Heights
Job State Location: NJ
Job Country Location: USA
Salary Range: $150,000 to $230,000
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