Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.    Job #02522 About our client Our client is a pharmaceutical company and works to develop, manufacture and market pharmaceutical therapies indicated for diseases/medical conditions requiring specialized treatment. The company’s prescription drugs are marketed both nationally and internationally. It caters to therapeutic categories of antiviral and anti-fungal agents. Position Location Director of Regulatory Affairs Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Contribute to developing sound regulatory strategies to support registration filings and approval of new products 2) Maintain contact with regulatory authorities as required on any and all issues related to the submission and approval of product dossiers 3) Contribute to the preparation, submission and approval of all regulatory submission (including but not limited to INDs, ANDAs, 505(b)(2) applications, NDAs, BLAs, DMFs, meeting and briefing packages) 4) Interact with regulatory authorities during product development, including support for FDA meetings and teleconferences (as needed) 5) Provide action plans to mitigate/eliminate the critical needs, including the need to bring in regulatory consultants on an as-needed basis to fill expertise gaps 6) Contribute to the maintenance and regulatory management of all registration dossiers for all marketed products as well as any products under development 7) Identify areas of organizational weakness from a regulatory perspective 8) Contribute to the development of an effective and efficient 3RP (Regulatory Affairs) organizational structure 9) Interact with FDA and outside consultants to resolve issues and evaluate change control requirements that will impact products 10) Identify appropriate personnel resources and hire as necessary to meet 3RPs defined business and project objectives Requirements 1) BA/BS degree 2) 8+ years of experience in pharmaceuticals 3) Minimum 5 years of hands-on experience in regulatory affairs 4) 3-5 years of supervisory experience 5) Familiarity with manufacturing facilities/sites and extensive experience in auditing such facilities/sites 6) Membership and certification in application professional organizations a plus 7) Ability to perform with minimal supervision 8) Demonstrated technical leadership as well as project and group leadership skills 9) Ability to interact with diverse departments to initiate and complete projects in a timely manner 10) Established favorable reputation with FDA and other regulatory authorities 11) Ability to set policies within the department and influence policy setting both within other groups and at the corporate level 12) Good management skills to manage and supervise staff or consultants
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