Kara Mcmahon Email & Phone Number

United States

United States

In this role, I will act as primary contact and Subject Matter Expert for the State licensing process required by the various States to either manufacture drug product or distribute drug product in the U.S. or its territories. Responsibilities:• Effectively administer 100% on-time renewals for the 300+ licenses/permits currently held by Sanofi for either drug manufacturing or drug distribution. • This includes payment of fees, submission of all required documentation, and resolution of any identified deficiencies required to maintain regulatory compliance in all States.• Communicate with various business stakeholders to ensure timely completion of any documentation that may be needed for licensure renewals or licensure applications. Initiate licensure applications on behalf of Sanofi for new legal business entities and advise on timing for potential approval based on each State’s licensure approval process and historical knowledge. • Implement deliverables relative to State licensure approvals by target dates. • Maintain industry knowledge to anticipate impacts from new laws.• Stay current with proposed rule changes in the various state legislatures regarding drug distributor or manufacturer regulation and provide feedback on those rule changes when solicited for comment by the State Board(s) of Pharmacy and/or Department(s) of Health. • Interpret complex legal language, rules, and laws as written by the various States, and clarify any uncertainties through additional research so that a thorough understanding is achieved. • Create clear, concise communications that are relevant and appropriate for target cross-functional audiences. • Advise appropriate parties within Sanofi (Business Entities, Supply Chain, Legal) how proposed changes to state laws may affect Sanofi’s licensure status as drug manufacturer or distributor.