Global Program Lead, Global Regulatory Affairs

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving 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. Bridging the gap between disruptive discovery products and real-world patient reach, we 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.

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

For our Regulatory Affairs department in Lausanne, we are looking for a:
Global Program Lead, Global Regulatory Affairs (100%)

Reporting to the Global Head of Regulatory Affairs, the Global Program Lead, Regulatory Affairs (Associate Director / Director level depending on experience) will be actively involved in supporting the development of innovative new medicines which are part of the Debiopharm’s portfolio. The portfolio includes small molecules, biologics, and radiopharmaceuticals. In this role, you are the Regulatory Affairs (RA) representative on assigned Project teams and will define development paths, covering from first-in-human up to registration, that maximize the value of our compounds and enable early access to patients with high unmet medical need. You will also be accountable for the implementation of the regulatory strategy. You will ensure compliance to applicable regulations and relevant processes for your activities, as well as those of more junior RA team members assigned to support you in specific tasks. Additionally, you will support in
- and out-licensing activities.

**Your responsibilities will be but not limited to**:
Lead, develop and implement the global RA strategy for assigned project.
Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams
Present and defend regulatory plans to Debiopharm internal governance bodies
Represent Debiopharm as the primary interface for FDA/EMA/other Regulatory Agencies on assigned projects, including coordinating and leading meetings with these Agencies.
Be accountable for the preparation 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
Work closely with functional experts to coordinate their contributions to regulatory documents
Review and approve documents of regulatory relevance such as Clinical Study Protocols, Clinical Study Reports, Statistical Analysis Plans, DSURs, etc
Manage and oversee external vendors, such as CROs
Contribute to the assessment of new in-licensing opportunities and represents RA in out-licensing teams
Maintains knowledge of global competitive and regulatory landscape
Contribute to the assessment of the impact that 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.
Leads regulatory sub-teams, as appropriate.
Coaches junior RA professionals and may have line function management responsibilities.
**Requirements**:
Bachelor’s degree in life-sciences; a higher degree is preferred
At least 10 years of regulatory affairs experience in the field of innovative new drugs, preferably in oncology or anti-infectives, with thorough knowledge of the overall drug development process. Experience with regulatory strategies for life-cycle management is an additional asset.

**Demonstrated experience with**:
Development and implementation of regulatory strategies for innovative new drugs, from pre-clinical stages up to registration. Experience with NDA/MAA submissions or post-marketing activities is an additional asset
Leading cross-functional teams for preparation of regulatory deliverables
Various regulatory procedures in the U.S. and Europe; experience with regulatory procedures in other jurisdictions is an additional asset
Managing and overseeing regulatory activities for global clinical trials up to phase III.
Leading meetings with Regulatory Agencies
You are independent, results driven, team-oriented with the ability to work in cross-functional teams within a matrix organization
Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously
Demonstrate excellent written and verbal communication skills in English

**Benefits**:
An international and highly dynamic environment, with a long-term vision
The opp