Job Description
Global Drug Regulatory Affairs leader & core member of a global program/brand team. Global responsibility for development/marketed product regulatory strategy covering development, regulatory submission, approval and life cycle management of the assigned project(s). 1) Regulatory Strategy: Development of strategic approach and global regulatory input to achieve optimal development and life cycle management plans in line with Established Medicines Business goals. 2) HA Interactions: Accountable for ensuring effective regulatory interactions; Develops global regulatory strategy and plans for Health Authority (HA) interactions with GPT. 3) Submissions and Approvals: Ensure optimal and timely submissions and approvals.Lead the global submission planning process. 4) Prescribing Information: Accountable for developing the Development Core Data Sheet (DCDS) with the GPT, consistent with development data and commercial objectives of the Target Product Profile (TPP) and for implementation of CDS and TPP into labels in major regions. 5) Compliance: Accountable for ensuring regulatory compliance for assigned projects. 6) Promotional Review: Responsibility for DRA review of global promotional materials. 7) Managerial: Management of direct/indirect reports; leads DRA subteam consisting of one or more GPRM’s and other DRA line functions.
Desired Skills & Experience
PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience Fluency in English (oral and written) 3 - 6 years of involvement in regulatory and drug/biologic development spanning activities in Phases I-IV; Demonstrated Innovation in developing and executing regulatory strategy; Prior history with post- marketing/brand optimization strategies and commercial awareness preferred; Involvement in a CTD/MAA submission and approval with proven HA negotiations experience; Drug regulatory submission and commercialization experience; Proven ability to analyze and interpret efficacy and safety data; Regulatory operational expertise.1 - 2 years of demonstrated leadership and accomplishment in regulatory affairs in a global/matrix environment in the pharmaceutical industry; Strong management, interpersonal, communication, negotiation and problem solving skills; Organizational awareness (e.g., interrelationship of departments, business priorities), including experience working crossfunctionally and in global teams.
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