[Hiring] Manager/Senior Manager, Global Regulatory Affairs @Menarini Group

Role Description

The Manager/Senior Manager of Global Regulatory Affairs Oncology is a member of the Global Regulatory Affairs Oncology department. He/she will be a key contributor for the successful development of Stemline/Menarini's pipeline and responsible for assisting with the implementation of the regulatory strategies for the oncology portfolio. He/She will work with the Global Regulatory Lead to provide overall regulatory guidance and oversight for all assigned products to obtain the optimal label and the shortest timing to approval by Regulatory Agencies. In this role, he/she will implement the global regulatory strategies and registration requirements for one or more products/regions.

• 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 into clinical, labelling, protocols, reports, presentations, and other documents.
• Coordinate the preparation, review and submission including responses to Agencies’ questions and requests, meeting requests, briefing packages, annual reports, etc.
• Identify and assess regulatory risks associated with assigned project responsibilities and assist in defining strategies to mitigate risks.
• Assist GRL in building and maintaining relationships with relevant regulatory agencies, contractors and corporate partners.
• Coordinate the preparation, review and submission of marketing applications.
• 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 analyse 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 upon for all projects within area of responsibility.
• Document regulatory contacts with Health Authorities.
• Manage regulatory data and information 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 track record of managing submissions.
• Experience in an Oncology therapeutic area is highly desirable.
• Prior experience in managing and submitting INDs, CTAs, BLA, 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 as well as in a multi-disciplinary team, and with external partners and Regulators.
• Ability to represent the department in project teams.
• Demonstrate strong organizational skills, including the ability to prioritize workload.
• Knowledge and understanding of applicable regulations.
• RoW regulatory experience is desirable.
• Direct experience of interfacing with relevant regulatory authorities is a plus.
• Experience managing relationships with contractors and CROs also preferred.

Requirements

• Please note: this position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Benefits

• Base Salary Range of $135,000-$180,000.
• Menarini Stemline offers generous compensation and benefits packages, including Fidelity 401(k) (with company match).
• Anthem Premier PPO and HDHP insurance plans.
• Company paid Basic Life & AD&D insurance and pre-tax FSA/HSA programs.

Company Description

Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.

• The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world.
• Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States.
• Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites.
• Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours.
• The acquisition of Stemline Therapeutics in June 2020 further strengthened Menarini’s oncology portfolio.