Global Program Regulatory Manager (GPRM)
Posted on Aug 9, 2019 by Harvey Nash IT Recruitment Switzerland
For our client in Basel we are looking for Global Program Regulatory Manager (GPRM) for 6-month contract.
Job title: Global Program Regulatory Manager (GPRM)
Duration: 01/09/2019 to 29/02/2020
Global Program Regulatory Manager(GPRM) in Regulatory Affairs, Early Development provides regulatory leadership for early projects (pre-first in human) in the Company portfolio. This individual functions as a core member of Early Development Teams to define the optimal regulatory strategy for first in human studies and work with franchise Regulatory Affairs to develop an expedient path to proof of concept (POC) that also enables full development. The GPRM will have cross franchise project responsibility through sPOC and planning for first in human (pre-IND meetings, etc.) and the work with the franchise DRA and DRA operations to optimize strategies from first in man to Development Decision Point (DDP). The GPRM serves as a regulatory expert for NIBR and early development teams to assure an understanding of regulatory process and compliance. The GPRM supports NIBR driven licensing activities and biomarker strategies, and provides internal regulatory advice to NIBR on compliance and operational issues.
. Develop regulatory strategies for projects in the NIBR portfolio (both small molecule and biologics programs) assuring regulatory guidance is provided to teams from the time of candidate selection through first in man/POC. Assure a smooth transition of all programs into the development portfolio, across business franchises in general medicines.
. Provide global regulatory direction and evaluate regulatory risks/gaps and trade-offs for the overall ED development plan with a focus on efficient global planning for first in human studies. Develop contingency plans for identified risks in the regulatory strategy.
. Follow closely industry and health authority actions and guidance's in novel technologies, such as advanced cell therapies, assuring the NIBR scientists and teams have a state of the art understanding of the current regulatory environment in these fast moving fields, actively participate in NIBR scientific forums to share critical learning.
. Work with Development DRA leadership and NIBR teams to align project milestones and risk benefit analyses with the goals of assuring a smooth transition from NIBR to development for all programs, both internal and in-licensing opportunities.
. Drive global approaches to early development strategies, considering novel approaches to timely POC outcomes. Provide regulatory guidance on biomarker strategies. Lead interactions with regulatory consultants for strategic input and challenges, particularly for novel technologies and therapeutic approaches.
. Provide regulatory input into NIBR driven licensing activities including technologies and M&A proposals, assuring regulatory risks are identified. Take regulatory lead on transition teams as ap-propriate.
. Assure understanding of regulatory compliance/best practice in the NIBR organization, identify training needs as appropriate training. Assure an operational understanding of the Company regulatory process is in place in Company teams, identify gaps that require training. etc
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