Sr Manager, Regulatory Affairs

Job description

The Sr Manager, Regulatory Affairs provides strategic leadership for and oversight of the Lifecycle (Postmarket) Regulatory team accountable for Advita’s postmarket regulatory affairs, i.e., regulatory support of commercialized products. Accountabilities include activities such as assessment of proposed changes for regulatory impact, regulatory strategy and support for change projects, compliance with Conditions of Approval, EU renewals and regulatory review & approval of advertising and promotion. The Sr Manager, Regulatory Affairs will partner with the business (e.g., BUs, Operations, etc.) and regulatory colleagues (e.g., the BU, Regional and RO & RCoE RA teams) to develop and execute global regulatory strategies in support of commercialized products.