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Job #03055

About our client Our client is a publicly traded pharmaceutical company headquartered in Pennsylvania. The company develops generic therapeutics for the treatment of various diseases. The company has an excellent track record with regulatory agencies and an experienced management team. Position Location Regulatory Affairs Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Formulate regulatory strategy and tactics for all appropriate regulatory submissions (e.g. ANDAs, dossiers, amendments and supplements) for domestic, international and/or contract projects 2) Coordinate, prepare and review all appropriate regulatory submission within a specified time frame in conjunction with the organization 3) Provide project management support to the Labeling Specialist in developing and reviewing draft as well as final printed product labeling 4) Coordinate and review development of promotional labeling with marketing 5) Act as a contact representing regulatory affairs with FDA, business units, contract customers and international customers (as assigned) 6) Coordinate and review submission bi-annual drug listing with Regulatory Labeling Specialist 7) Review and analyze regulatory and related publications to ensure compliance and anticipate future regulatory actions (internally and externally) Requirements 1) Bachelor's degree in a scientific/healthcare discipline or equivalent combination of education and related experience 2) Minimum 5 years of pharmaceutical industry experience 3) 4+ years of experience in pharmaceutical regulatory affairs 4) Experience of NDA and ANDA submission 5) Previous experience of managing overseas staff in India 6) In-depth understanding of ICH and FDA guidelines 7) Proficiency with electronic document management and electronic submissions 8) Ability to formulate regulatory strategy and tactics (e.g. legal, labeling, clinical, filing, etc.) to support filing of a regulatory submission 9) Demonstrated ability to work in a team environment 10) Excellent communication skills (oral and written) 11) Willingness to travel to Asian Countries (up to 50%)