Senior Director, Regulatory Affairs

Melinta Therapeutics LLC • Parsippany-Troy Hills, NJ

7h • Hybrid

About The Position

The Senior Director of Regulatory Affairs provides strategic leadership and formulates comprehensive regulatory strategies for product development and life cycle management of approved products, ensuring ongoing compliance with applicable regulatory requirements. This role is pivotal in facilitating proactive and effective interactions with regulatory bodies to secure timely and favorable regulatory decisions.

Requirements

• Full lifecycle experience from early development to managing marketed products
• Strong project management and computer skills (including Microsoft office)
• Demonstrated strong leadership and management skills; proven ability to work with very little guidance/supervision with a proactive approach
• Global regulatory management experience
• Experience with Post Marketing Requirement and PREA commitments
• Knowledge of Global Labeling Guidance, Drug Development and Commercialization of prescription medicines
• Highly collaborative and works with ease in matrix environment
• Minimum of 10 years pharmaceutical experience and 8 years regulatory experience in in drug development and registration activities

Responsibilities

• Provides high-level strategic leadership and direction for regulatory activities, including submission preparation, defense, and interactions with regulatory authorities for new and ongoing clinical and surveillance programs, including labeling negotiations
• Oversees and interprets regulations, guidelines, procedures, and policies related to the development and global registration of drug products, with a specific focus on clinical development and global registration
• Leads and advises regulatory and clinical teams, providing expert guidance to clinical CROs, regulatory vendors, and area authors/reviewers on submission and dossier requirements
• Acts as the primary point of contact with regulatory authorities, fostering strong working relationships with internal clinical team partners, project consultants and contractors, and external CROs
• Develops and implements comprehensive regulatory strategies and operations, ensuring timely delivery of all regulatory submissions
• Creates and executes detailed regulatory submission project and resource plans, sets goals, and tracks progress towards critical milestones for major regulatory submissions
• Provides regulatory insights and input into new business venture activities, contributing to strategic decision-making
• Effectively addresses and resolves regulatory authority and business partner questions and concerns, ensuring compliance and alignment with business objectives
• May have oversight of 1-2 Regulatory affairs personnel

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 11-50 employees