Description
Major Accountabilities:Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
Provides input into global regulatory strategy and contributes to Regulatory FunctionalPartners with regions to align on regulatory strategy in order to fulfil business objectives.
Works with other department to plan and facilitate presentations to regulatory boards on regulatory strategy
Coordinates and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders.
Determines requirements and sets objectives for Health Authority (HA)
Interacts directly with HAs as appropriate in meetings with other departments and external stakeholders
Coordinates and plans rehearsals for HA meetings.
Facilitates preparation and finalization of briefing books.
Develops and implements plans for timely response to HA requests and coordinates responses.
May serve as local HA liaison depending on location (e.g., FDA or EMA).
Responsible for integrating global strategy into regional submissions worldwide.
Coordinates, plans, and prepares for submission of dossiers in assigned regions worldwide.
Review of global dossier summary documents.
Contributes to development and implementation of plans to avoid delays during submission review.
Responsible for submission of Clinical Trial Applications (CTAs) and Investigational New Drugs(INDs).
Contributes to the development of the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS)with DRA GPT representative
Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning.
Revise labels as needed to achieve timely HA approval with best possible label based on available data.
Responsible for ensuring necessary updates or required reviews of local labeling and to capture deviations to maintain alignment with the CDS in conjunction with DRA GL.
Requirements:
Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred.
Fluency in English as a business language. Additional language is an asset
Experience with regulatory submission and approval processes in 1 or more major regions.
Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
Experience in HA negotiations.
experience in regulatory and drug/biologic development spanning activities in Phases I-IV in the following areas: Innovation in regulatory strategy, Understanding of post-marketing/brand optimization strategies and commercial awareness
HA negotiations.
Drug regulatory submission and commercialization in region.
Analysis and interpretation efficacy and safety data.
Regulatory operational expertise.
Strong interpersonal, communication, negotiation and problem solving skills.
Basic organizational awareness (e.g., interrelationship of departments, business priorities)
Michael Bailey International is acting as an Employment Business in relation to this vacancy.