Manager/ Director Clinical Regulatory Affairs, USRA VaccinesPosted: October 29, 2009
Manager/ Director Clinical Regulatory Affairs, USRA Vaccines Requisition ID: 54682 Position: Full-Time Regular Open date: Sep 3, 2009 5:42:15 PM Functional area: Regulatory Affairs Location: King of Prussia, Pennsylvania Required degrees: Bachelors Level Degree Experience required: 6 years Relocation: Not Indicated Basic qualifications: At least 6 years relevant experience in Pharmaceutical development. . Strong scientific background . Excellent organizational skills . Excellent written and oral communication skills . Ability to strategize, problem solve and influence in matrix team setting . Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent . First degree (Science) higher degree desirable; At least 6 years relevant experience in Pharmaceutical development with biologics experience preferred. . Experience in providing strategic advice on integrated Clinical development plans and problem solving in cross-functional teams in drug/vaccine development. Preferred qualifications: . Significant experience in Vaccine/Biologic Clinical aspects of Regulatory Affairs or development . Significant presence in/contributions to external organizations pertaining to regulation of product development preferably vaccines/biologicals . Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to Clinical product development , preferably vaccines/biologicals . Experience in liaison with major regulatory Agencies, preferably FDA . Interest/experience in cross-training in CMC aspects of RA is desirable Details: US Development Strategy Responsible for proposing plans and managing Clinical regulatory aspects of development and strategic plans leading to US approvals and life cycle management for assigned projects; consolidate, communicate and maintain current regulatory plans ensuring alignment with Head Therapeutic Area Regulatory Affairs FDA Filing Strategy Responsible for managing Clinical regulatory aspects of US filing strategies for IND, BLA and supplements for assigned projects FDA Liaison Responsible for liaison for Clinical RA with FDA reviewer level staff Submissions Content Responsible for data-driven messaging, content and format of all Clinical submissions and ensure readiness of documentation for review within Therapeutic area of USRA prior to HLA review; includes planning of desired documentation, review and revision of drafts and resolution of content issues with USRA supervisor, RA Central/data-generating groups in all Project Teams for assigned projects US Submissions Operations Responsible representative in interactions with USRA Operations planning and publishing teams to ensure coordinated and timely submission of accurate Clinical dossiers/e-dossiers for assigned projects US Labeling Support Responsible representative for interactions with US Labeling group and with multifunctional US Label Review Teams providing Clinical RA support, advice and preparations of deliverables for assigned projects: includes draft and final package inserts, packaging, container labels US Business and Marketing Support Advisory role in providing strategic regulatory and operational copy approval to US business and marketing teams for assigned therapeutic area in agreement with Head Therapeutic Area, USRA Contact information: You may apply for this position online by selecting the Apply now button.
Please refer to job code glaxo-147907 when responding to this ad.
| Category: | Biotech/Pharmaceutical |
|
> Regulatory Affairs
| | Location: | King of Prussia, PA | | County: | Montgomery County | | ZIP Code: | 19406 | | Pay Rate: | Open | | Job Terms: | full time | | Company: | GlaxoSmithKline | | Phone: | email only please | | Fax: | email only please |
|
