Global Regulatory Affairs Oncology Manager

Menarini Group; New York (NY); On-site; USD 135,000 - 180,000; Full time

Job summary

Menarini Stemline seeks a Manager/Senior Manager of Global Regulatory Affairs Oncology to guide regulatory strategies for the company’s oncology portfolio. The role involves coordinating submissions, building relationships with regulators, and ensuring timely approvals across regions.

The candidate should have 2–4 years in regulatory affairs with US/EU experience, preferably in oncology. The position offers a competitive base salary in the US, with comprehensive benefits and an international

Qualifications

• BA/BS in Life/Health Sciences required.
• 2–4 years of Regulatory Affairs experience.
• EU/US regulatory experience preferred.
• Experience in Oncology therapeutics desirable.
• Experience managing INDs, CTAs, BLA, NDAs, MAAs, and lifecycle management.
• Proven ability to deliver within timelines and communicate with regulators.

Responsibilities

• Support preparation, review, and submission of health authority documents.
• Coordinate submissions and responses to agency questions.
• Identify regulatory risks and help define mitigation strategies.
• Assist in managing relationships with regulators, contractors, and partners.
• Develop global regulatory strategies for assigned products/regions.
• Ensure submissions comply with regulations and guidelines.
• Manage submission plans and timelines to meet objectives.
• Analyze competitive and regulatory guidance to strengthen strategies.
• Contribute to Target Product Profile with cross-functional teams.
• Collaborate with global, regional, and local counterparts.
• Document regulatory contacts and manage information systems.

Skills

Regulatory Affairs

INDs/CTAs/BLA/NDAs/MAAs

EU/US regulatory experience

Oncology experience

Stakeholder communication

Project management

Education

BA/BS Life/Health Sciences

Job description

Menarini Stemline seeks a Manager/Senior Manager of Global Regulatory Affairs Oncology to guide regulatory strategies for the company’s oncology portfolio. The role involves coordinating submissions, building relationships with regulators, and ensuring timely approvals across regions.

The candidate should have 2–4 years in regulatory affairs with US/EU experience, preferably in oncology. The position offers a competitive base salary in the US, with comprehensive benefits and an international