Manager Regulatory Affairs

Job Purpose

Development Strategy

Participates in the creation of plans and manages global (including US) CMC regulatory aspects of development and strategic efforts leading to investigational activities, market application approvals and life cycle management. Consolidates, communicates and maintain current regulatory plans ensuring alignment with Head, Worldwide Regulatory Strategy, Immunotherapeutics and Director, TRU. Exposure to clinical development and how technical aspects need to be integrated is a plus.

Filing Strategy

Writes technical and/or non-clinical parts of regulatory submissions. Defines/writes technical response to inquiries from global regulatory authorities. Critically reviews results/data for appropriate quality and compliance with applicable global regulatory guidance/legislation; for consistency with previously submitted information and established strategy; advise on how to best position results.

Liaison with Authorities

Participates in liaison activities specific for CMC RA topics with global regulatory authorities under oversight of Head, Worldwide Regulatory Strategy, Immunotherapeutics and Director, TRU.

Submissions Content

Helps to create data-driven messaging, content and format of all CMC submissions and ensure readiness of documentation for review within Business Unit prior to HLA review; includes planning of desired documentation, review and revision of drafts and resolution of content issues with TRU management and Head, WW Regulatory Strategy, Immunotherapeutics. Manages preparation of regulatory documents: plan, define and seek endorsement for content and timeline.

Submissions Operations

Interacts with regulatory operations planning and publishing teams to ensure coordinated and timely submission of accurate CMC dossiers/e-dossiers.

Labeling Support

Interacts with with labeling group(s) and with multifunctional label review teams providing CMC support, advice and preparations of deliverables for assigned projects: includes draft and final package inserts, packaging, container labels

Policy/Regulatory Policy

Builds internal and external contacts (collaborators, Health authorities) to ensure efficient and timely preparation of files and documents in compliance with current regulatory expectations and standards. Contributory role in interactions with internal and external policy groups targeted for influencing/shaping new regulatory policy and legislation by commenting on draft guidance, regulatory, scientific and policy documents.

Profile

Specialized Knowledge:

• First degree (Science) higher degree (MS or PhD) desirable;
• At least 6 years relevant experience in Pharmaceutical development with biologics experience preferred.
• Experience in providing strategic advice on integrated CMC development plans and problem solving in cross-functional teams in drug/vaccine development
• Requires scientific and regulatory knowledge pertinent to CMC development aspects RA
• Operational knowledge of global regulations pertinent to product CMC development , preferably vaccines/biologicals.

Basic Requirements:

• Strong scientific background
• Sound knowledge of Technical Regulatory requirements and strategies
• Sound knowledge of GSK Bio products
• Good command of written and spoken English
• Excellent organizational skills
• Excellent written and oral communication skills
• Ability to strategize, problem solve and influence in matrix team setting

Preferred Attributes

• Significant experience in Vaccine/Biologic CMC aspects of Regulatory Affairs or development
• Working knowledge of application of US regulations preferred.
• Experience or working knowledge of development of small molecules is a plus
• Experience in liaison with major regulatory Agencies
• Exposure to clinical development aspects is a plus