Manager/Senior Manager, Global Regulatory Affairs

Stemline Therapeutics Inc (Menarini Group) · Permanent position

About the role

The Manager/Senior Manager of Global Regulatory Affairs Oncology is a member of the Global Regulatory Affairs Oncology department and a key contributor to the successful development of Stemline/Menarini's oncology pipeline. The role assists with implementing regulatory strategies for the oncology portfolio, working with the Global Regulatory Lead to provide overall regulatory guidance and oversight for assigned products to obtain optimal labels and the shortest timing to approval by regulatory agencies. The position implements global regulatory strategies and registration requirements for one or more products/regions, which may involve multiple indications, formulations, or external business partners. The role operates in an international environment and contributes to developing the network and expanding the knowledge of the GRA Oncology team.

Responsibilities

• Support the preparation, review, and submission of health authority documents as required, including marketing applications, responses to agencies' questions and requests, meeting requests, briefing packages, annual reports, etc.
• Represent GRA as a team member and provide relevant regulatory strategy input into clinical, labeling, protocols, reports, presentations, and other documents.
• Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
• Assist the Global Regulatory Lead in building and maintaining relationships with relevant regulatory agencies, contractors, and corporate partners.
• Ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions.
• Manage submission plans and timelines to ensure approvals and development objectives are timely met.
• Review and analyze competitors' information, recent product approvals, local public Advisory Committee proceedings, and global agencies' guidelines to support the development of strong regulatory strategies.
• Contribute to the development of the Target Product Profile in collaboration with various line functions.
• Interact with key stakeholders in multiple departments at all levels.
• Collaborate with global/regional and local (country) counterparts to ensure global/regional regulatory strategy is defined and executed for all projects within area of responsibility.
• Document regulatory contacts with health authorities.
• Manage regulatory data and information within systems.

Requirements

• BA/BS or 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 track record of managing submissions.
• Experience in an Oncology therapeutic area 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 work with and 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, individually and in multi-disciplinary teams, and with external partners and regulators.
• Ability to represent the department in project teams.
• Strong organizational skills, including the ability to prioritize workload.
• Knowledge and understanding of applicable regulations.
• RoW regulatory experience desirable.
• Direct experience interfacing with relevant regulatory authorities a plus.
• Experience managing relationships with contractors and CROs preferred.

Pay

Base salary range: $135,000–$180,000. Per the New York employer