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Project management of all Gx new submissions for defined markets.
Works on a variety of generic products for a certain defined area, Strategy preparation, tracking projects, reviewing and resolving issues, acting as a main point of contact for affiliates and regional supporting functions.
RA delegate within project teams and assuring execution of optimal regional/local affiliates regulatory submission strategies.
Strategic and operational regulatory support to affiliates in the defined area.
Close collaboration with stakeholders globally, in the region and in-country including regulatory affairs, R&D, portfolio, supply chain and commercial.
Manages, coordinates and consolidates files suitability & feasibility for portfolio's wish lists and files due-diligence reports; gaps analysis and mitigation plans for strategy PRC in alignment with COREX centers teams.
Discuss with R&D projects in development prior to project allocation, ensuring that the regulatory activities are set and are in line with market requirements; i.e. attendance and active participation in selection meetings, introduce RA strategy input in PLM, and provision of FSD and submission timelines.
Proactive Project management of submissions execution according to submissions WP, tracking progress and interact with the regulatory staff affiliates as needed. Provide support to local affiliates by opening bottle necks to ensure on-time submission and launches.
Takes responsibility from strategy definition until launch and act as the RA delegate for regional functions forums including R&D and Portfolio.
Have an overview of the entire projects registration status for a defined area until launch.
Internally works in interface with RA officers in the RA centers and with regional maintenance & compliance manage
Minimum 5 years’ experience in Regulatory Affairs or R&D, preferably with experience in a similar role.
Degree in life sciences/ pharmacy or equivalent qualification(s)/experience
Excellent team-work and communication skills
Ability to think and act strategically
Drive for results and excellence
Proven project management skills and attention to details
Good knowledge of the industry
Confidence and communication skills are important for managing relationships both internally and externally