Job Purpose and Key Responsibilities:
Development Strategy for diagnostic companion to therapeutic assets
Responsible from GSK for proposing plans and managing technical and, as appropriate, clinical regulatory aspects of development and strategic plans leading to regulatory approvals and life cycle management for companion diagnostics associated with various biological products in the Immunotherapeutic portfolio; consolidate, communicate and maintain current regulatory plans ensuring alignment with Head, WW Regulatory Strategy, Immunotherapeutics. Includes direct, primary liaison with development and commercialization partners, consultants and advisors, some of whom may have primary responsibility for the actual development activities outside of GSK. Includes involvement in development and registration strategy for the companion biological product and liaison with USRA Oncology.
Filing Strategy
Responsible for managing GSK contributions to regulatory aspects of filing strategies for documentation associated with diagnostic investigation and registration, including PMA, CE Mark, IPMF, etc. for companion diagnostics for immunotherapeutic biologic portfolio. This includes direct, primary regulatory liaison with partner companies, consultants and other advisors for development and commercialization of companion diagnostics, some of which might have primary responsibilities for regulatory filings outside of GSK.
Liaison to Authorities
Responsible for or participates in liaison for diagnostic aspects with global regulatory authorities.
Submissions Content
Responsible for GSK aspects and GSK oversight of 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 supervisor, RA Central/data-generating groups in all Project Teams for assigned projects. Includes direct, primary regulatory liaison to development and commercialization partners who may have primary responsibility for regulatory submissions; must ensure GSK oversight and alignment with all GSK strategic plans and interests.
Submissions Operations
Responsible representative or active participant/representative in interactions with USRA Operations and/or development/commercial partner planning and publishing teams to ensure coordinated and timely submission of accurate clinical dossiers/e-dossiers for assigned projects
Labeling Support
Responsible GSK representative or active participant/representative for interactions with GSK US Labeling and/or labeling representatives of development/commercial partner and with multifunctional Label Review Teams providing GSK RA support, advice and preparations of deliverables for assigned projects: includes draft and final package inserts, packaging, container labels
Business and Marketing Support
Advisory role or active representative in providing strategic regulatory and operational copy approval to business and marketing teams in agreement with Head, WW Regulatory Strategy, Immunotherapeutics. May include strategic regulatory input to business initiatives relevant to securing of development and commercial diagnostic partners.
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 and Diagnostic arena policy interactions.
Profile
Specialized Knowledge:
- First degree (Science) higher degree desirable; At least 6-7 years (grade dependent) relevant experience in diagnostic and/or pharmaceutical development with biologics experience preferred.
- Experience in providing strategic advice on integrated development plans and problem solving in cross-functional teams.
- Scientific and regulatory knowledge pertinent to CMC and clinical development aspects of biologics is preferred.
- Operational knowledge PMA, 510k, CLIA; experience or exposure to CE Mark and related global regulations relevant to diagnostics 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 diagnostic aspects of RA or development – US focus
- Experience/exposure to global RA development and requirements for diagnostics
- Some experience/exposure to vaccines/biologics development and regulation
- Significant presence to external organizations pertaining to regulation of diagnostic products