Manager/Senior Manager, Global Regulatory Affairs

Menarini Stemline is a pharmaceutical company committed to high quality therapeutics and diagnostics solutions. The Manager/Senior Manager of Global Regulatory Affairs Oncology will be responsible for implementing regulatory strategies for the oncology portfolio and ensuring timely approvals from regulatory agencies.

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. Represents GRA as a team member and provides 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
• Interacts with key stakeholders in multiple departments at all levels
• Collaborates 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

Preferred

• Life / Health Sciences preferred
• EU/US regulatory experience preferred, including track record of managing submissions
• Experience in an Oncology therapeutic area is highly desirable
• 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
• Life Sciences
• Health Sciences
• EU regulatory experience
• US regulatory experience
• Oncology experience
• RoW regulatory experience
• Regulatory authority interface
• Contractor relationship management
• CRO relationship management

Benefits

• Generous compensation and benefits packages
• 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

Company

• Develops innovative oncology therapeutics for cancer treatment
• New York, New York, USA
• http://www.stemline.com/
• Founded in 2003
• 501-1000 employees

Qualifications

• BA / BS / University degree required
• 2-4 years of Regulatory Affairs and relevant drug/biologic development experience
• 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
• Life / Health Sciences preferred
• EU/US regulatory experience preferred, including track record of managing submissions
• Experience in an Oncology therapeutic area is highly desirable
• 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
• 2-4 years of Regulatory Affairs and relevant drug/biologic development experience.

Required skills

• BLA Submission, CTA Submission, Contractor and CRO Relationship Management, Drug/Biologic Development, EU Regulatory Experience, Health Authority Document Preparation, IND Submission, Life Cycle Management, MAA Submission, NDA Submission, Oncology Therapeutic Area, Regulatory Affairs, Regulatory Data Management, Regulatory Guidelines Knowledge, Regulatory Risk Assessment, Regulatory Strategy, Regulatory Submissions Management, US Regulatory Experience

Preferred skills

• Life / Health Sciences preferred, RoW regulatory experience is desirable

Experience

• 2-4 years