Description

As the Director of Global Regulatory Affairs CMC Marketed Products Development, you will manage regulatory submissions and lifecycle activities while leading a team to ensure compliance with global regulations. This role involves collaborating with various stakeholders and Health Authorities to enhance communication and decision-making processes.

Requirements

• •BS/BA Degree in a Scientific Discipline, Advanced Degree preferred
• •10+ years pharmaceutical Regulatory CMC experience or equivalent industry experience
• •Experience with active pharmaceutical ingredient/drug substances, small molecules, drug products, biologics, analytical characterization, process scale-up or regulatory registration of products
• •Expert in developing alternate strategies based on guidance/regulations
• •Expert in liaising with Regulatory Agencies as lead in successful Agency Interactions
• •Understanding of scientific principles and regulatory CMC requirements relevant to global drug development
• •Ability to deal with issues of critical importance and provide regulatory advice
• •Able to provide sound strategic advice and enable critical decisions under ambiguity
• •Demonstrate leadership, problem-solving ability, flexibility, and values teamwork
• •Demonstrate strategic enterprise thinking and ability to influence in a complex matrix environment
• •Exercise good judgement in elevating and communicating issues to line management
• •Build and maintain a team environment that inspires and enables progress
• •Expert in CTD authoring and/or review skills throughout the product lifecycle

Tasks

• •Manage regulatory submissions for global marketing applications
• •Oversee post-approval lifecycle activities for assigned compounds
• •Evaluate change proposals for global regulatory impact
• •Plan global variations and amendments
• •Interpret EMA, FDA, ICH, and WHO regulations for CMC compliance
• •Lead team in establishing CMC content requirements for regulatory submissions
• •Review submission content for compliance with established requirements
• •Communicate developments impacting regulatory success to project teams and stakeholders
• •Provide solutions to prevent recurrence of regulatory issues
• •Interact with international Health Authorities and facilitate agency meetings
• •Stay updated on evolving regulatory CMC requirements
• •Apply regulatory knowledge to projects and support colleagues' development
• •Maintain constructive relationships with colleagues and Health Authority representatives