Regulatory Affairs Senior Specialist

Job Description: A Global Pharmaceutical company based inCaliforniais looking for a Senior Regulatory Affairs Associate to add to their expanding team. The Senior Associate works cooperatively with all regional regulatory sites to support the accurate and timely communication of critical information and monitor information from multiple regulatory and change control systems to capture regional change within regulatory Essential Responsibilities: - Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements - Responsible for submitting regulatory documents including safety reports, amendments, supplements and license renewals to trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for specific geographical areas - Initiate local process improvements and contribute to local and / or global process improvements, which directly impacts the Regulatory Affairs department team - Maintains current knowledge of regulatory requirements and relays changes in regulatory information to project teams and senior management in a timely manner - Provides support for cGMP activities pertaining to regulatory affairs Qualifications: - BA degree and minimum 4 years of relevant experience in Regulatory Affairs - Work is performed under limited supervision of a Senior Regulatory Affairs associate - Capability of leading a small team in preparation of submissions. - Excellent verbal and written communication skills and interpersonal skills are essential - Must be knowledgeable of regulatory requirements, including ICH requirements and regional requirements for specific designated areas

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com/en/