Senior Manager - US Regulatory Affairs Lead-Oncology - Remote

Overview

The Senior Manager - US Regulatory Affairs Lead for Oncology will support one or more products from a regional regulatory perspective, developing and implementing regulatory strategies while managing effective agency interactions.

In Short

• Develop and implement regional regulatory strategies.
• Manage regulatory submissions for clinical trials and marketing applications.
• Ensure compliance with local laws and regulations.
• Collaborate with stakeholders to define regional needs.
• Lead development of regional regulatory documents.
• Advise on regulatory implications related to global clinical development plans.
• Participate in cross-functional teams to align on regulatory strategies.
• Communicate with regulatory agencies and manage interactions.
• Provide regulatory direction for product development.
• Support the safety and efficacy of investigational medicinal products.

Requirements

• Doctorate degree and 2 years of regulatory experience, or Master’s with 4 years, or Bachelor’s with 6 years.
• Experience in contemporary oncology regulatory affairs.
• Strong understanding of regulatory processes and legislation.
• Ability to communicate scientific information effectively.
• Negotiation skills and cultural awareness.
• Experience with regulatory submissions and agency interactions.
• Ability to anticipate regulatory agency responses.
• Good oral and written communication skills.
• Ability to resolve conflicts and develop beneficial outcomes.
• Comprehensive understanding of the regulatory environment.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plan with company contributions.
• Group medical, dental, and vision coverage.
• Flexible work models, including remote work arrangements.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Work/life balance initiatives.
• Inclusive work environment.