Dir, Sr Regulatory Affairs

Description This position is responsible for the regulatory liaison function and the implementation of regulatory strategies of company product(s) in development. Responsibilities include management of the preparation of regulatory filings and completion of submissions required for INDs, CTAs, NDAs and MAAs. Responsible for developing strategies/timelines, conducting meetings, acting as liaison with regulatory authorities, participating in inspections, budgeting, and presenting project plans to management. Works closely with other functional areas such as Clinical Development, Project Management, Manufacturing, Quality and Marketing. Is also an integral part of R and D project teams. Position Requirements MS/PhD/MD/PharmD Minimum 10 to 15 years experience in pharmaceutical industry or equivalent, with significant experience as a company representative at health authority meetings and global regulatory representative of company development projects. Proven ability to develop and defend regulatory strategies for projects. Experience in and a thorough understanding of the preparation of scientifically valid submissions and the translation of regulatory requirements into practical plans. Demonstrated work experience in all phases of drug registration and approval, from pre to post launch. Must be able to interpret and apply government regulations. Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills. Exceptional cross functional team leadership skills. Ability to work in close collaboration with others. Strong organizational and planning skills, as well as strong attention to detail. Accountable for results and goal attainment. Experience with electronic submissions requirements and the review of technical reports prepared in support of regulatory filings. Ability to work independently with limited supervision, adapt to change and manage multiple tasks. Ability to problem solve and make decisions on complex issues, often in a cross functional team setting. Technical knowledge of US regulations and ICH and GXP Guidelines. Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management. Apply for this Job