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 #02839 About our client Our client is a leading drug company with close to $10B in sales and over 10,000 employees worldwide. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Scientist, Regulatory Affairs San Francisco, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and implement regulatory strategies to facilitate the development and ultimately, approval of drugs/biologics for human use 2) Serve as primary liaison with regulatory authorities and manage the strategy and execution of these interactions 3) Communicate and promote teamwork with Project Team members and development partners 4) Serve as the regulatory representative on a minimum of one project and represent a complete regulatory strategy (both CMC and commercial) 5) Lead the Regulatory sub team 6) Provide regulatory due diligence assessments in cooperation with business development 7) Present regulatory strategies and issues to corporate committees/senior management 8) Manage projects within a 3 – 6-month planning horizon 9) Make sound and independent decisions 10) Lead cross-functional teams for coordinating regulatory submissions 11) Work collaboratively with business partners 12) Lead and participate in departmental initiatives, task forces and training 13) Provide leadership in researching, recommending and implementing new processes in the department/company 14) Maintain current knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics Requirements 1) Bachelor’s degree in Science (advanced degree preferred) 2) 7+ years of experience in regulatory affairs or a related position with a CRO or pharmaceutical/biotech company 3) Experience in and knowledge of drugs (not medical devices) 4) Good decision-making skills 5) Superb interpersonal and relationship-building skills 6) Excellent (independent) leadership, negotiation and problem-solving skills 7) Ability to work well under pressure and influence without authority 8) Ability to work in a team environment 9) Flexibility and willingness to adapt in a changing environment
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