To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03646

About our client Our client is a biopharmaceutical firm based in the California. They boast a strong product pipeline in clinical and pre-clinical stages for 10 different therapeutic areas. With an experienced management team and the chance to take on a leadership role, this is a great opportunity for the right candidate! Position Location Director of Regulatory Affairs California Salary Highly competitive package, commensurate with experience Responsibilities 1) Facilitate new product development through the development and execution of global regulatory strategies and effective regulatory agency interactions 2) Provide regulatory guidance and supervision for key development programs that involve non-clinical, clinical and CMC development components 3) Lead the preparation, planning and execution of strategic or complex regulatory submissions 4) Oversee development of submission content, documents and timeline for complex projects 5) Identify potential risks in complex submissions and communicate appropriately 6) Demonstrate effectively and establish an environment that focuses on the continuous improvement of submission management 7) Advise key groups on submission requirements of internal and external influence 8) Facilitate alignment with multiple businesses, regional and country stakeholders 9) Develop solutions to regulatory or business problems where no clear precedence exists 10) Provide input into regulatory vision and develop operational plans 11) Anticipate expectations of regulators and identify strategic opportunities to improve ability to meet regulators’ expectations 12) Understand external regulatory policy and industry standards and communicate impact to projects and provide direction to interpret 13) Participate in establishing compliance with regulatory procedures and systems and demonstrate leadership in assigned areas of responsibility 14) Educate internal stakeholders on implications of regulations 15) Maintain ongoing compliance with regulatory procedures and systems as well as regulator interactions 16) Plan, coordinate, prepare and execute meetings with regulatory agencies on complex and strategic programs 17) Negotiate complex issues with regulatory bodies 18) Build and manage relationships, proactively with regulators to better position and ensure a positive outcome 19) Provide direction and resolve complex issues for more junior-level team members 20) Interact with managerial level regulatory agency teams as appropriate 21) Submit and manage projects 22) Communicate to project teams’ potential changes in regulations and/or guidance and assess the impact 23) Manage positive relationships and influence internally with other functions 24) Identify opportunities based upon interpretation of the regulations and guidance 25) Network internally as well as across functions and divisions to gather knowledge and information Requirements 1) BS/MS in a related scientific field preferred 2) Minimum 5 years of experience in regulatory affairs in the pharmaceutical industry 3) Record of successful FDA and EU submissions (INDs, NDAs, etc.)