Director Global Regulatory Affairs – Companion Diagnostics/In Vitro Diagnostics

Job Description

Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, efficient, and compliant drug/diagnostic regulatory strategies and approaches across geographies.

Under direction of the Executive Director, Companion Diagnostics/In Vitro Diagnostics, the Principal Scientist/Director will be responsible for:

• Providing critical strategic and tactical CDx/IVD regulatory guidance that positively influences project planning and decision making. 

• Developing regulatory strategies for assigned products (non-oncology/oncology) to enable and/or support timely approval of both therapeutic and diagnostic products by regulatory agencies.

• Representing the Global CDx Regulatory position and providing updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners. 

• Coordinating and leading regulatory interactions with diagnostic partners and/or regulatory health authorities, as needed, to mutually align on co-development needs and expectations for major project tasks such as regulatory submissions (e.g., PMAs, 510(k)s, IVDR submissions to NB, IDEs, EU performance study applications, pre-submissions). 

• Reviewing and authoring relevant sections of diagnostic regulatory submissions, as appropriate, and corresponding therapeutic dossiers.

• Interacting with global regulatory authorities and diagnostic partners to determine best practices and least burdensome regulatory paths to facilitate development and global registration activities.

• Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products. 

• Providing regulatory support for due diligence activities, as needed.

Minimum education required:

Required: Bachelor’s degree in biological science, chemistry or related discipline, with minimum of 10 years of relevant experience in diagnostics and/or medical devices, the majority of which must be in diagnostic regulatory affairs. 

Preferred: M.S. with minimum of 8 years of relevant regulatory experience; PharmD or PhD with minimum of 6 years of relevant regulatory experience.

Required Experience and Skills: 

• Diagnostics/In Vitro Diagnostics. Experience in Oncology/non-oncology companion/complementary diagnostic development is preferred.

• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.  

• Outstanding interpersonal communication and negotiation skills. 

• Demonstrated leadership attributes and ability to drive success consistent with company values and priorities.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth …