Alfasigma USA seeks a Regulatory Affairs Director to lead the regulatory and compliance efforts. The Regulatory Affairs Director will be housed in our Bedminster, NJ. office and will directly report to the Chief Integration Officer. This person will be responsible for designing and implementing a viable regulatory strategy that provides a speedy and optimal access of new products to the market while ensuring that the regulatory status of Alfasigma USA (ALUSA) products is fully compliant and updated in accordance with applicable US regulations and Alfasigma Group internal policies. Masters the different regulatory environments as required and engages with government bodies, external consultants, and industry associations to discuss and protect ALUSA interests.
Designs and implements regulatory strategies to grant a speedy and optimal access of new products (Medical Foods, Medical Devices and Prescription drugs) to the market.
Ensures full compliance with Regulatory and Pharmacovigilance legislation and guidelines.
Engages with government bodies, external consultants, and functional industry associations.
Supports the Manufacturing Quality and Technical Groups.
Alfasigma USA is the local footprint for the Italian based pharmaceutical company, Alfasigma. Alfasigma was formed as a result of a merger between two historic Italian pharmaceutical companies, Alfa Wassermann and Sigma-Tau. Alfasigma is a top five pharmaceutical company in Italy. They research, produce and market prescription drugs, medical foods and OTC products. The newly created Alfasigma USA’...s main goal to expand on the existing portfolio and incorporate new products into the US market. Alfasigma USA's main mission is to provide patients with alternative and safe solutions to improve their quality of life. We strive to be a strong, healthy company in a strong healthy world. Alfasigma USA is headquartered in Covington, LA., has a manufacturing plant in Shreveport, LA., a mail order pharmacy call center in Mandeville, LA. and an established national salesforce. They also have an office in Bedminster, NJ which houses our commercial operations.