A leading global pharmaceutical company that specialise in the development of biological therapies is advertising a vacancy for a Global Program Regulatory Manager -
Junior position. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
Based in Switzerland, this is an exciting opportunity to work with an internationally renowned establishment.
Job Responsibilities :
Developing regulatory strategies for projects in the company 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.
Assuring a smooth transition of all programs into the development portfolio, across business franchises in general medicines.
Providing global regulatory direction and evaluating 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.
Following industry and health authority actions and guidance in novel technologies, such as advanced cell therapies, assuring that scientists and teams have a state-
of-the-art understanding of the current regulatory environment in these fast-moving fields, and actively participating in scientific forums to share critical learning.
Working with Development DRA leadership and company teams to align project milestones and risk benefit analyses with the goals of assuring a smooth transition from company to development for all programs, both internal and in-
Driving global approaches to early development strategies, considering novel approaches to timely POC outcomes.
Providing regulatory guidance on biomarker strategies.
Leading interactions with regulatory consultants for strategic input and challenges, particularly for novel technologies and therapeutic approaches.
Providing regulatory input into company-driven licensing activities including technologies and M&A proposals, assuring regulatory risks are identified.
Taking regulatory lead on transition teams as ap-propriate.
Understanding regulatory compliance / best practice in the organisation, identifying training needs as appropriate training.
Assuring an operational understanding of the regulatory process in the Biomedical Research teams, identifying gaps that require training.
Skills and Requirements :
Demonstrable multitasking, project management, and execution skills.
Good interpersonal skills, including communication, presentation, persuasion, and influence.
Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
Proficiency with computer skills, such as MS Office.