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Job #03168

About our client Our client is a top 10 pharmaceutical company that has established a reputation as one of the most desirable companies to work for in North America. With operations around the globe and an empowering corporate culture that is focused on the professional development of its employees, this is a strong opportunity for the right candidate. Position Location Director, Regulatory Intelligence New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct screening of draft and final legislation/guidelines and other information on drug development and regulatory matters issued by European, Japanese, US and other important health authorities 2) Identify guidelines that may have a direct impact on company’s ethical products, drug development or the performance of Global Regulatory Affairs 3) Communicate (appropriately) the identified documents and their potential impact within GRA and to other relevant functions within the company 4) Coordinate and guide reviews of relevant draft guidelines by functions and/or Global Regulatory Affairs 5) Coordinate reviews of the generated company positions by an agreed review process (as laid down in the internal process description on guideline commenting) 6) Ensure that alignment on one position is obtained between all affected functions and regions so that the company speaks with one voice on regulatory topics to the outside world 7) Guide general information gathering on agency benchmarks regarding approval 8) Review times and general regulatory performance indicators 9) Summarize and analyze internal and external data 10) Develop proactive relationships with selected external industry associations 11) Maintain membership of industry associations, regulators and other pharmaceutical companies to exchange information, identify and influence regulatory/industry trade association initiatives 12) Compile and maintain an overview of recommended external experts/suppliers of regulatory expertise 13) Collect regulatory competitor information (for select projects) related to regulatory submission strategies and bases for approvals in close cooperation with other relevant functions 14) Maintain an effective regulatory intelligence database to provide regulatory intelligence services for development projects and for marketed products 15) Provide information regarding regulatory requirements, competitor environment and external regulatory experts to allow GRA functions to anticipate and effectively implement new regulatory compliance obligations Requirements 1) BS 2) 10 years of experience in regulatory affairs with 5 years in regulatory intelligence 3) Experience in a regulatory affairs environment and knowledge of Health Authority divisions, personnel and procedural concepts 4) In-depth knowledge of regulatory affairs and regulations as they apply to regulatory activities 5) Excellent network with other companies 6) Diplomatic, scientific and technical expertise 7) Understanding of the organization for the dissemination of regulatory intelligence information 8) Knowledge of drug regulations and guidance documents on drug development, variations and line extensions in all main countries 9) Excellent networking, negotiation and influencing skills 10) Good communication skills (verbal and written) 11) Fluent in English (German an asset) 12) Ability to maintain associations and stakeholders and to successfully negotiate 13) Ability to work within a global team framework and a multi-cultural environment 14) Ability to focus on multiple issues simultaneously and organize diverse activities in a changing environment (often under time pressure) 15) Ability to fully understand regulatory processes and also the critical questions being addressed across the value chain 16) Ability to work strategically 17) Ability to influence and build relationships with regulatory bodies 18) Politically savvy with excellent technical knowledge 19) Willingness to travel – both domestic and international (30% – 40%)