Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07278 About our client Our client is a pharmaceutical company headquartered in North Carolina that is focused on the development and commercialization of various therapeutics for neurological diseases. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Director of Regulatory Affairs NC Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Oversee the development and approval of products, ensuring close collaboration among all groups 2) Direct FDA regulatory strategies and support for all development drug products 3) Ensure that company products are approved on a timely basis 4) Lead cross-function project teams in FDA negotiations for the therapeutic area 5) Demonstrate ability to contribute, in a leadership role, to fastest development and approval of the drug product 6) Maintain positive and proactive collaborations with Legal, Technical Research and Development, Sales and Marketing and Operations departments 7) Review submissions for appropriate scientific rationale and strategic impact critically 8) Direct resources utilization of the department in order to maximize efficiency 9) Ensure that time lines are met 10) Develop people and processes for continuous improvement in the RA Department Requirements Qualifications / Skills Required 1) 7 years or more experience in regulatory affairs in a pharmaceutical environment 2) Solid oral dosage experience 3) Strong knowledge and experience in US regulatory affairs 4) Significant line management experience of multidisciplinary scientific and technical staff 5) Good working relationships with various FDA members at the divisional level 6) Strong command of the drug development process, pharmaceutical business and strategic portfolio management 7) Strong entrepreneurial spirit with a track record of taking intelligent risks, courage in decision-making and willingness to be held accountable 8) Competence in analysis and problem-solving 9) Ability to prioritize and make trade-offs to achieve goals 10) Ability to interact effectively across boundaries with other functional groups 11) Willingness to push teams to think strategically, creatively and proactively 12) Management experience coupled with strong interpersonal, oral and written communication skills with ability to train and develop direct reports
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