Regulatory Affairs Specialist

Job Summary:

Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects.

Responsible for:

Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio

Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products

Collaboration with partners to develop and execute global regulatory activities

DMF preparations, review of changes and routine updates to Global Regulatory Agencies

Dossier preparations of Biosimilar biologics for ICH regions Key Activities: Regulatory Strategy and Execution

Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements

Provide regulatory direction on global regulatory requirements to support product development Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle

Support development and execution of clinical/non-clinical strategies

Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration

Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans

With minimal supervision, participate in development of risk management and contingency planning

Ensure and lead regulatory compliance for biosimilar products

Participation in regulatory meetings with Health Authorities Regulatory Intelligence:

Monitor, assess and implement global regulatory requirements, guidelines, and policies relating to biosimilar products

Review and assess impact of regulatory decisions for competitive products

Generate and communicate biosimilar intelligence Collaboration:

Partner with regulatory team members to research and communicate relevant regulatory information regarding biosimilar products

Identify process needs to meet internal challenges

Escalate regulatory issues, progress, and metrics to the GRA Biosimilars function Knowledge and

Skills

Comprehensive understanding of Regulatory activities

Regulatory experience with product filings

Team skills, especially in working with internal and external partners

Familiarity with project management requirements

Ability to understand and communicate scientific CMC information

Anticipate and prevent potential issues

Ability to communicate regulatory strategies and requirements to ensure expectations are understood DMF preparation and updates Briefing book preparation for scientific advices and related administrative tasks leading to submission

Education

Doctorate degree OR Master's degree