Associate Regulatory Affairs Director

Accountabilities/Responsibilities

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverables, including submission delivery strategy of all dossiers and all application types per market and/or region.
• Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs).
• Analyze regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices when handling various applications and procedures during interactions with health authorities.
• Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle.
• Lead GRST & GRET sub-teams, i.e. cross-functional submission delivery teams for major submissions (NDA/MAA or major LCM initiative).
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects and highlight unforeseen changes in resource demand.
• Identify regulatory risks and communicate mitigations to Lead RPM and cross-functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, TMF, and document management.
• May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
• Provide coaching, mentoring and knowledge sharing within the RPM skill group.
• Contribute to process improvement.
• When assigned Lead RPM role: lead the GRET, own project management of all GRET deliverables, serve as key member of the GRST, drive the GRST and GRET resourcing process, support fee forecasting, allocate RPM resources, and liaise with GPM and other functional project managers.

Minimum Requirements – Education and Experience

• Bachelor Degree and 3+ years experience or Masters Degree and 1+ years experience
• Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority
• Thorough knowledge of drug development
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

Preferred Experience

• Managed first wave Marketing Application and/or LCM submissions
• Managed complex regulatory deliverables across projects/products
• Knowledge of AZ Business and processes