Reporting to the Chief Medical Officer, you will be responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.
Act as liaison between Regulatory Affairs and other functional areas including CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents for submission to governmental regulatory agencies.
Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory documents requirements
Integrate global regulatory understanding and responsibilities in developing strategy
Provide regulatory expertise and support nonclinical and clinical areas for investigational products
Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements and provide regulatory support for corporate quality assurance efforts.
Identify and assess regulatory risks for assigned projects or programs
Prepare and deliver effective presentations for external and internal audiences
Participate and contribute in Health Authority meetings
Minimum M.S. degree in life/health/technical sciences required
Minimum of 5 years’ experience in a biotech and/or pharmaceutical environment, including 4-5 years in Regulatory Affairs
Knowledge of global regulatory requirements
Experience with IND preparation and submission
Experience in immunology preferred
Must be a team player that can handle multiple tasks simultaneously in a fast-paced company
Demonstrate excellent communication skills
Ability to represent the function in project teams
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
Experience in interfacing with relevant regulatory authorities
Experience in interpretation of regulations, guidelines, policy statements, etc.