Careers

Title: Director, Global Regulatory Labeling Lead

Location: Waltham, MA

About the Company

Entasis Therapeutics (Nasdaq:ETTX) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including SUL-DUR (targeting A. baumannii infections) being evaluated in a Phase 3 registration clinical trial, zoliflodacin (targeting Neisseria gonorrhoeae) being evaluated in a Phase 3 registration clinical trial, and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections).

 

Position Summary

In this newly created position, the Global Regulatory Labeling Lead (Director) will be responsible for the design and execution of global labeling strategies and guidance to core labeling documents, including product labels, Target product / Target label profiles and Company Core Data Sheet (CCDS) for all Entasis programs. This role will report to the Vice President, Head of Global Regulatory Affairs.

 

Key Responsibilities:

  • Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies through own expertise and research on labeling precedence
  • Develop and ensure proper review, approval, implementation, maintenance, distribution and tracking of global labeling documents, including product labels, Target Product/Label Profile, CCDS for all Entasis products
  • Optimize the processes and procedures associated with the integration of regulatory strategy and tactics in the development of the company Target Label Profile and the CCDS based on the Target Product Profile
  • Integrate overall business objectives into departmental labeling goals and standardize /develop labeling SOPs and processes utilizing industry labeling best practices
  • Ensure that all company and regional labeling processes are reviewed periodically, kept up to date and in line with strategic priorities, compliance with regulatory requirements and Entasis quality standards to ensure commercial product integrity
  • Establish and manage relationship with labeling vendors/consultants/contractors to ensure effective implementation of labeling processes to meet business needs and regulatory requirements
  • Monitor and analyze appropriate regulatory agency labeling guidance and policies and assess impact on Entasis programs
  • Monitor industry labeling trends and propose actions as appropriate
  • Lead the development of new strategic and operational initiatives to improve the efficiency of Global labeling and labeling operations as appropriate

 

Qualifications:

  • BS or equivalent in life or health sciences discipline; Masters or PhD in life or health science discipline preferred
  • 10+ years of pharmaceutical industry experience; inclusive of 8 years of labeling experience or combination of 6+ years regulatory and/or related experience
  • Understanding of scientific principles and regulatory/quality systems relevant to drug development
  • Knowledge of global standards regulatory regulations, guidelines, policy statements, etc. related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred)
  • ·Demonstrate strategic thinking, change leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively
  • Demonstrate independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identifies issues; offers creative solutions and strategies and make appropriate recommendations/decisions, including risk mitigation strategies
  • Experience in interfacing with regulatory agencies and at external industry meetings
  • Demonstrate excellent leadership, communication and influencing skills internally (cross-functional teams) and externally at all levels of the organization 
  • Highly effective oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
  • Demonstrate strong organizational skills, including the ability to prioritize workload

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