Global Regulatory Affairs Leader, Diagnostics Solutions

Regulatory Toolkit; Indianapolis (IN); On-site; USD 347,000 - 455,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Roche is seeking a Global Head of Regulatory Affairs based in Indianapolis to lead global regulatory registrations and enable global access to our diagnostics solutions. You will build and mentor a high-performing RA team, partner with regional leaders, and drive strategies that align with Roche Diagnostics’ vision.

You will champion VACC leadership and foster collaboration with cross-functional partners to shape regulatory strategy and ensure timely submissions across markets.

Qualifications

• Fifteen+ years regulatory management experience in international and US contexts.
• Experience in Dia or MedTech or both.
• Proven track record of filings (510ks, PMAs, IDEs) and FDA interactions.
• Experience leading diverse, global teams in matrix organizations.
• Strong leadership and strategic thinking.

Responsibilities

• Provides strategic direction for Global Regulatory Submissions with leadership of teams in Europe, US and APAC.
• Acts as regulatory contact with US FDA, international bodies, and Affiliates.
• Ensures timely availability of registration data and dossiers for rapid patient access.
• Monitors global regulatory environments and assesses impact of new regulations.
• Drives development of best-in-class regulatory processes, practices and submission strategies.
• Manages resources across RA teams in alignment with Lifecycle teams.
• Drive process standardization and reuse of common assets and standards.
• Fosters an agile mindset to deliver high quality submissions.
• Leads RA team consistent with Roche values and leadership commitments.
• Inspires the team to deliver breakthrough diagnostics solutions.

Skills

Regulatory leadership

Global regulatory

Strategic thinking

Stakeholder management

Matrix leadership

Communication

VACC leadership

Budget management

Education

Post-graduate degree

University degree in relevant field

Job description

Roche is seeking a Global Head of Regulatory Affairs based in Indianapolis to lead global regulatory registrations and enable global access to our diagnostics solutions. You will build and mentor a high-performing RA team, partner with regional leaders, and drive strategies that align with Roche Diagnostics’ vision.

You will champion VACC leadership and foster collaboration with cross-functional partners to shape regulatory strategy and ensure timely submissions across markets.