Sr. Associate Director/Director Regulatory Affairs Digital Endpoints (m/f/d)

REFERENCE NUMBER:

523504/1

MY DUTIES:

- Embedded in Regulatory Affairs Innovation and supporting cross functional teams.
- Works as an integral part of the RA Innovation group (imbedded) and ensures compliance with global regulatory requirements and adherence to regulatory internal policies and processes
- Provides regulatory leadership on digital endpoint development supporting drug development teams in alignment with company approach. Digital endpoints may involve the use of SaMD, ePRO, eCOA, and sensors (medical devices and/or consumer grade)., and experience with these technologies is preferred
- Develops high quality regulatory strategy and health authority engagement plans. Supports HA interactions, including the preparation and finalization of briefing books, rehearsals for HA meetings and responses to HA questions
- Supports key regulatory submissions including CTAs, INDs, 510Ks, PMA, IDEs, NDAs, drug dossiers and device clearance planning processes. Identifies requirements, issues, gaps, and trade-offs affecting optimal and timely registration/clearance., for assigned projects
- Provides input into the Development Core Data Sheet (DCDS) and Core Data Sheet (CDS) for digital-technology supported drugs along with the drug regulatory lead.  

MY QUALIFICATIONS:

- Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph. D, PharmD) preferred
- Fluency in English as a business language. Additional language is an asset.
- Strong knowledge of regulatory development, submission and approval processes in 1 or more major regions for drugs and medical devices, including digital devices (preferred). Digital endpoints are developed at the company solely to support drug development and so in-depth knowledge of drug development is key
- Experienced in leading teams in health authority negotiations and making regulatory submissions
- Works effectively in a highly matrixed organization, managing expectations and collaboratively working across groups and divisions
- Exhibits strong leadership skills
- Strong communication, collaboration skills, writing and problem solving skills
- Ability to work independently

MY BENEFITS:

- Option for extension
- You will work in an international environment 

PROJECT INFORMATION:

- Our customer is one of the biggest pharmaceutical company 

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Natascha Hanser

Reference number
523504/1

Contact
E-Mail: [email protected]