Director US Clinical Regulatory

Job Purpose and Key Responsibilities:

US Development Strategy for therapeutic assets

Responsible for proposing plans and managing clinical regulatory aspects of development and strategic plans leading to US approvals and life cycle management for assigned projects; consolidate, communicate and maintain current regulatory plans ensuring alignment with Head, WW Regulatory Strategy, Immunotherapeutics and Director, USRA Oncology/ASCI. Includes involvement in development strategy for biologics as well as companion in vitro diagnostics. Also includes liaison with USRA Oncology.

US Filing Strategy

Responsible for managing clinical regulatory aspects of US filing strategies for IND, BLA, MF, PMA and supplements for assigned projects.

US FDA Liaison

Responsible for or participates in liaison for Clinical RA aspects with US FDA, Center for Biologics and Center for Devices and Radiologic Health.

Submissions Content

Responsible for data-driven messaging, content and format of submissions and ensure readiness of documentation for review within Business Unit and Global RA prior to HLA review; includes planning of desired documentation, review and revision of drafts and resolution of content issues with USRA supervisor, RA Central/data-generating groups in all Project Teams for assigned projects

Submissions Operations

Responsible representative or active participant/representative in interactions with USRA Operations planning and publishing teams to ensure coordinated and timely submission of accurate clinical dossiers/e-dossiers for assigned projects

US Labeling Support

Responsible representative or active participant/representative for interactions with US Labeling group and with multifunctional US Label Review Teams providing Clinical RA support, advice and preparations of deliverables for assigned projects: includes draft and final package inserts, packaging, container labels

US Business and Marketing Support

Advisory role or active representative in providing strategic regulatory and operational copy approval to US business and marketing teams for assigned therapeutic area in agreement with Head, WW Regulatory Strategy, Immunotherapeutics

Regulatory Policy

Contributory role in interactions with US Policy Groups and initiatives as needed to support assigned projects: includes support for preparations for Regulatory and Scientific Policy Meetings/Trade Meetings/Key Opinion Leader interactions, Oncology arena policy interactions and CBER/Pharma Liaison as needed

Profile

Specialized Knowledge:

• First degree (Science) higher degree desirable; At least 5-6 years (grade dependent) relevant experience in Pharmaceutical development with biologics experience preferred. Experience in diagnostics a plus.
• Experience in providing strategic advice on integrated Clinical development plans and problem solving in cross-functional teams in drug/vaccine development
• Requires scientific and regulatory knowledge pertinent to CMC development aspects of RA
• Operational knowledge of IND and BLA regulations and experience in US regulations pertinent to Clinical product development, preferably vaccines/biologicals; experience in diagnostics development and regulatory requirements a plus.
• Experience in liaison with major regulatory Agencies, preferably US FDA

Basic Requirements:

• Strong scientific background
• Excellent organizational skills
• Excellent written and oral communication skills
• Ability to strategize, problem solve and influence in matrix team setting
• Demonstrated knowledge in regulatory affairs and drug/vaccine development or equivalent

Preferred Requirements

• Significant experience in vaccine/biologic clinical aspects of RA or development
• Some experience/exposure to diagnostic/device development and regulation
• Significant presence to external organizations pertaining to regulation f product development, preferably vaccines/biologics