Director, Commercial Regulatory Affairs (CORA)

About the role

Roche is hiring Directors in Commercial Regulatory Affairs (CORA), a function within the Global Product and Access Legal organization. Directors are senior strategic advisors and people leaders who help commercial and medical affairs leaders navigate regulatory and business risk in communicating about Roche's disease areas and products. They advise on FDA laws, regulations, guidance, enforcement precedents and other health-authority requirements, and they lead, coach and oversee a team of regulatory professionals.

Key responsibilities

• Advise U.S. and global commercial leaders on advertising, promotion, disease awareness and product-communication matters, applying FDA and other health-authority rules to proposed strategies
• Lead and manage regulatory affairs professionals, reviewing significant assessments and ensuring advice is consistent across products and therapeutic areas
• Lead assigned commercial review committees and serve as the senior CORA and GPAL regulatory representative, coordinating with GPAL attorneys and outside counsel
• Monitor FDA warning and untitled letters, enforcement activity, litigation, guidance and rulemaking, and turn them into strategic advice for Legal and business leaders
• Represent CORA externally to industry bodies, associations and regulatory authorities, including managing FDA communications and regulatory submissions
• Design and lead the implementation of team strategy and set standards for regulatory risk assessment
• Lead, develop and coach a team, overseeing onboarding, performance management and talent succession
• Proactively address compliance risks and oversee CORA compliance priorities, SOPs/DOPs and functional excellence initiatives

Required profile

• Bachelor's degree (life sciences, law, public policy, marketing, business, education or related); graduate degrees such as JD, MBA, MS, PharmD or PhD strongly preferred
• 10+ years of work experience in regulatory, legal, compliance or policy roles