Regulatory Affairs Sr Manager

About the role

Formulate and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Technical Operations, R&D, Commercial and other internal stakeholders, as needed, across investigational and marketed products.

Responsibilities

• Develop risk register for all major regulatory submissions outlining potential regulatory risks and proposals for mitigation strategies
• Coordinate and collaborate on the preparation of CMC components of regulatory submissions
• Provide guidance for and contribute actively to the development of CMC related documents for regulatory submissions, Health Authority Meetings Requests, and Briefing Books, ensuring that they meet current regulatory standards including guidance and expectations are high quality consistent, complete and approvable on the first review cycle
• Develop strategies for and collaborate on preparation of responses to CMC-related topics with health authorities
• Review manufacturing/testing change controls and provide regulatory impact assessments
• Responsible for representing and supporting CMC regulatory on multidisciplinary project teams and providing CMC regulatory guidance
• Ensure compliance with Health Authority expectations and regulatory guidance
• Maintain a knowledge base of current and emerging CMC regulatory environments, guidelines and best practices, and interpret and communicate relevant issues to colleagues

Requirements

Master's degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or a related field & 6 years of experience in the job offered or in an Associate or regulatory-related occupation.

Qualifications

• Leading interactions with Regulatory Agencies including the preparation of briefing documents and the coordination of meeting logistics
• Organizing, preparing, or reviewing Chemistry, Manufacturing and Controls (CMC) content for clinical trial applications or marketing applications for submissions to health authorities
• Compiling Chemistry, Manufacturing and Controls quality data utilizing Veeva Vault quality and regulatory information management system
• Development and management of project timelines and deliverables
• Knowledge of International regulatory standards concerning drug development including Good Laboratory Practices, Good Clinical Practices, or Good Manufacturing Practices
• Knowledge of the Food and Drug Administration organization, roles, and responsibilities concerning drug development
• Analyze, summarize, and interpret scientific data with understanding of the applicable limitations of the data

Pay

The annual salary for this position in the U.S. is $185,619.00 per year.

Benefits

• Stock
• Retirement plan
• Medical, life and disability insurance
• Eligibility for an annual bonus (or for sales roles, other incentive compensation)

Schedule

Full Time position. May telecommute.