Global Regulatory Leader, In Vitro Diagnostics

Employment Type

: Full-Time

Industry

: Miscellaneous



YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Global Regulatory Affairs Leader, In Vitro Diagnostics, are to: 

Maintain oversight of regulatory strategies for all projects with a IVD/CDx component;
Develop and maintain the IVD/CDx strategy template;
Advise on IVD/CDx strategies that are aligned with oncology drug development;
Coordinate regulatory consultancy input into IVD/CDx regulatory strategies;
Provide IVD/CDx regulatory input to multiple development projects: o Advise GRSs on individual IVD/CDx regulatory strategies as part of the broader project regulatory strategy;
Contribute to CDx TPP development;
Provide IVD/CDx regulatory advice to Early Development Project Leaders / Biomarker Project Leaders / Early Clinical Leaders and the respective late development roles;
Provide specialist IVD/CDx input and reports to early and late GPTs;
Preparation and leadership of dialogue with HA representatives to support the acceptance of the IVD/CDx strategy;
Manage multiple IVD/CDx development partnerships;
Provide regulatory feedback on partnership contracts;
Build and maintain relationships with regulatory colleagues from the CDx partner companies;
Substitute for Regulatory representative on Joint Collaboration Committees, as needed;
Participate in project review meetings;
Propose ideas to facilitate improved collaboration;
Coordinate and prepare IVD/CDx regulatory documentation Submissions to Health Authorities or Ethics Committees;
Answers to HA and EC questions related to diagnostic testing;
Ensure partner IVD/CDx labeling and Instructions for Use is consistent with Bayer target labelling;
Contribute to internal regulatory IVD/CDx expertise development;
Establish and coordinate knowledge sharing platform within Regulatory Oncology and cross-functionally within Oncology SBU o Establish IVD/CDx Regulatory Community Group, contribute to Biomarkers Community group;
Develop and share Bayer Oncology Case Studies;
Design, prepare and implement training programs;
Monitor key changes in the global regulatory environment in the area of personalized medicine, with special focus on diagnostic tests;
Build the internal and external network; represent Bayer in
relevant industry associations;
Monitor and contribute to guidance in key regions including US, Europe, Japan and China;
Provide regular updates to all GRSs and other stakeholders / internal groups;
Identify priority areas and provide input to Regulatory Policy.


WHO YOU ARE

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

Advanced technical degree Ph.D., DVM, MD or Pharm D in life sciences preferred with 5 years in IVD / regulatory affairs / drug related development / medical research activities, OR MS degree with 8 years of IVD / regulatory affairs / drug related development / medical research activities, OR BS degree with 10 years of IVD / drug-related development / medical research activities.
At least 5 years of experience in IVD plus 2 years in regulatory affairs;  
Working knowledge of US and international medical device regulatory requirements; experienced with FDA interactions and submissions;
Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics is required;
Good understanding of IVD development process is required;
Excellent communication skills, verbal and written, and ability to effectively communicate with cross-functional teams;
Strong analytical skills are required; ability to find effective solutions for varied and complex problems;
Demonstrated leadership and project management skills, working across cultures, interpersonal and influence-management skills;
Fluency in the English language;
Sound knowledge of MS Office: Word, Excel, PowerPoint and MS Project.

Preferred Qualifications:

Experience in oncology;
Familiarity with regulatory issues and challenges associated with Drug/Diagnostic co-development;
Recent experience with IVD/drug co-development projects and understanding of drug development process in oncology.


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