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Job #03348

About our client Our client is a publicly traded life sciences company that is recognized as a leader in the parenteral packaging technology and components sector. The organization is highly profitable and boasts both an experienced management team and a global customer base. They have also developed an industry-wide reputation for their commitment to quality and innovation. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Director of Regulatory Affairs Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the establishment of systems and guide the activities of the RA organization that are in harmony with the company’s strategic initiative and the goals of the business 2) Develop services and initiatives with internal and external customers that bring value to the company and its customers, particularly with respect to the regulatory environment 3) Act as principle liaison with the FDA and other regulatory agencies as well as customers on regulatory matters 4) Develop, implement and coordinate regulatory strategy based on current regulations, industry best practices and the impact on company products and processes 5) Oversee all tasks for the submission of all DMF, 510(K) submissions and supplements (as required) 6) Formulate partnering initiatives with internal and external customers to develop, implement and expedite regulatory processes with global regulatory agencies 7) Support and develop the company's regulatory positions on various strategic issues relating to product, product usage and services 8) Develop variations in concepts that can be discussed for strategic positioning 9) Represent the company at professional meetings and as a member of key committees in industry associations that best serve the company’s interests 10) Share knowledge of trends and industry information with the appropriate departments within the company 11) Train and develop other members of the Regulatory Team via formal training plans 12) Educate external customers actively, on regulatory issues related to company products and services (positioned from a “value to customer” perspective) 13) Assist international sites (as needed) by giving them appropriate guidance and direction on regulatory issues 14) Provide continuous regulatory support and information during product development and production for products or services that are regulated by the FDA to ensure regulatory and customer expectations are met 15) Educate other internal groups actively on the company's customer regulatory process and services 16) Support other areas as requested Requirements 1) BA/BS in Life Sciences preferred (advanced degree preferred) with relevant business background 2) Hands-on performer with minimum 10 years of experience in RA with several years in leading, managing and mentoring other RA professionals 3) Minimum 5 years of experience in management with direct communication with the FDA 4) Practical experience in preparing, submitting and maintaining 510(k)s or IND/NDAs and other regulatory applications 5) Experience in pulling together the Drug Master File and keeping it current 6) Regulatory experience in working with a large pharmaceutical or medical device company a plus 7) Recent experience in a company that supports the medical device industry or pharmaceutical industry involved in API manufacturing, drug packaging or drug delivery systems 8) Working knowledge of the FDA (particularly the CMC section) 9) Knowledge of US regulations, cGMPs and ISO 10) Strong organizational skills 11) Familiarity with the IND, NDA and ANDA process and with packaging sections of CMC a substantial plus 12) Knowledge of regulatory trends and ability to anticipate new regulations 13) Excellent communication skills (written and oral) 14) Ability to work well with people