Global Program Regulatory Lead

Job content

Debiopharmis 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 Regulatory Lead(100%)

Reporting to the Global Head of Regulatory Affairs, the Global Program Regulatory Lead will be actively involved in supporting the development of innovative new medicines, including small molecules, biologics, and radiopharmaceuticals. The Global Program Regulatory Lead will be the RA representative on assigned Project teams and will define development paths that maximize the value of our compounds and enable early access to patients with high unmet medical need. The Global Program Regulatory Lead will also be accountable for the implementation of regulatory strategies spanning from first-in-human studies up to registration, including support to business development and out-licensing activities. Additionally, the Global Program Regulatory Lead will ensure compliance to applicable regulations and relevant processes in his/her activities, as well as those of more junior RA team members assigned to support specific tasks.

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
• Maintain 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.
• Lead regulatory sub-teams, as appropriate.
• Coach, supervise and may have line function management responsibilities of junior RA professional.

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 and French;

Benefits:

• An international and highly dynamic environment, with a long term vision.
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

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.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions