Global Regulatory Affairs Manager
vor 1 Tag
Description
Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.
At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
For our Regulatory Affairs organization based at our Headquarters in Lausanne, we are looking for a
Global Regulatory Affairs Manager
Working in a matrix environment, you will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics and radiopharmaceuticals. You will contribute with technical and operational expertise to the implementation of regulatory strategies. Additionally, you will ensure compliance to applicable regulations and relevant processes when performing assigned tasks.
**Your responsibilities will be but not limited to**:
Support a RA senior professional for the development and implementation of the global RA strategy for assigned projects,
Participate in the management of external vendors such as CROs
Contribute to the preparation and tracking of submissions in several jurisdictions, such as: INDs/CTAs, Briefing Documents to support meetings with Regulatory Agencies, Orphan Drug Applications, PIP/PSP, Fast Track / Breakthrough Designation/PRIME, etc.
Represent RA in cross-functional sub-teams, such as Clinical Study Teams
Participate in the review of documents of regulatory relevance such as Clinical Study Reports, DSURs, etc.
Work closely with functional experts to coordinate their contributions to regulatory documents
Maintain knowledge of global competitive and regulatory landscape and contribute to the assessment of the impact changes might have on assigned projects
Contribute to establishing and revising standard operational procedures to maximize the efficiency of processes and ensure compliance to regulations
**Requirements**:
Bachelor’s or Master’s degree in life-sciences, combined with at least 3 years of regulatory affairs experience in the field of drug development, including experience in managing clinical trials
You gained strong understanding of regulatory procedures in the EU and/or US
Knowledge of products in Oncology is an asset
You demonstrated excellent organizational, communication and time management skills needed to manage multiple ongoing tasks/projects simultaneously
You have strong analytical skills with a solution driven mindset
You are Independent, results driven and team-oriented, advocating the cross-functional collaboration
You are fluent in English (oral and written), French is an asset
**Benefits**:
International, highly dynamic environment with a long term vision.
Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success.
Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities
Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.
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