Manager/Senior Manager, Global Regulatory Affairs

About the role

The Manager/Senior Manager of Global Regulatory Affairs Oncology is a key contributor for the successful development of Stemline/Menarini's pipeline. Responsible for assisting with the implementation of the regulatory strategies for the oncology portfolio, this role works with the Global Regulatory Lead to provide overall regulatory guidance and oversight for assigned products to obtain the optimal label and the shortest timing to approval by Regulatory Agencies.

The position holder will implement global regulatory strategies and registration requirements for one or more products/regions, which may vary in complexity with multiple indications, formulations, or external business partners. This role operates in an international environment and contributes to expanding the knowledge and network of the Global Regulatory Affairs Oncology team.

Responsibilities

• Support the preparation, review, and submission of health authority documents, including marketing applications, responses to agencies’ questions, meeting requests, briefing packages, and annual reports.
• Represent Global Regulatory Affairs (GRA) as a team member, providing regulatory strategy input into clinical, labeling, protocols, reports, presentations, and other documents.
• Coordinate the preparation, review, and submission of regulatory documents, including responses to agencies’ questions and requests.
• Identify and assess regulatory risks for assigned projects and assist in defining strategies to mitigate risks.
• Assist the Global Regulatory Lead (GRL) in building and maintaining relationships with regulatory agencies, contractors, and corporate partners.
• Ensure consistency, completeness, accuracy, and adherence to regulations and guidelines for all regulatory submissions.
• Manage submission plans and timelines to ensure timely approvals and development objectives.
• Review and analyze competitors’ information, recent product approvals, local public advisory committee proceedings, and global agencies’ guidelines to support strong regulatory strategies.
• Contribute to the development of the Target Product Profile in collaboration with various line functions.
• Interact with key stakeholders across multiple departments and collaborate with global, regional, and local counterparts to define and execute regulatory strategies.
• Document regulatory contacts with health authorities and manage regulatory data within systems.

Qualifications

• BA/BS/University degree required; Life/Health Sciences preferred.
• 2-4 years of Regulatory Affairs and relevant drug/biologic development experience.
• EU/US regulatory experience preferred, including a track record of managing submissions.
• Experience in an Oncology therapeutic area is highly desirable.
• Prior experience managing and submitting INDs, CTAs, BLAs, NDAs, MAAs, and life cycle management.
• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively communicate with key stakeholders.
• Knowledge of regulations, guidelines, and policy statements.
• Proven ability to consistently deliver within defined timelines, cost, and quality standards.
• Excellent interpersonal skills with the ability to work in a global environment, both individually and in multi-disciplinary teams, and with external partners and regulators.
• Strong organizational skills, including the ability to prioritize workload.
• Rest of World (RoW) regulatory experience is desirable.
• Direct experience interfacing with regulatory authorities is a plus.
• Experience managing relationships with contractors and CROs is preferred.

This position is classified as a corporate office role. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of work location.

Pay

Base Salary Range of $135,000–$180,000.

Benefits

• Fidelity 401(k) with company match.
• Anthem Premier PPO and HDHP insurance plans.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.