Senior Manager Regulatory Affairs

• Supervision of assigned team members with respect to management, training, and resource planning
• Support of CMC filings including Investigational New Drug (IND)/Clinical Trial Applications (CTAs), Marketing Application/Authorization, post-approval supplement/variations, renewals, facility registrations, Module 3 baseline, annual reports and responses to agency request for Information across all countries.
• Collaboration with other leaders in the US and Singapore to ensure alignment across the teams
• Lead process improvements, documenting CMC processes and ensuring appropriate consultation with all stakeholders
• Providing expertise and guidance to interdepartmental and cross-functional teams
• Coaching and supporting junior regulatory staffs career development

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree and 2 years of directly related experience OR
• Masters degree and 8 to 10 years of directly related experience OR
• Bachelors degree and 10 to 14 years of directly related experience OR
• Diploma and 14 to 18 years of directly related experience

Preferred Qualifications:

• Preparation of global CMC submissions across all phases of development
• In-depth knowledge of global CMC requirements, including country specific documents for submissions
• Experience managing and leading regulatory strategies for submissions including but not limited to IND/CTAs, Marketing Application/Authorization, Facility Registrations and Renewals, Product Renewals, Annual Reports (investigational and commercialized products), post approval supplements/variations, etc.
• Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect
• Ability to work in a fast-paced environment while retaining a high attention to detail and quality
• Strong oral and written communication skills
• Strong interpersonal, collaborative, problem solving and conflict resolution skills
• Ability to develop solutions to technical and organizational issues to improve performance and productivity
• Flexible working hours to accommodate US, UK and Singapore time zones
• Degree in life sciences, biochemistry, or chemistry
• Experience in leading Global regulatory CMC submissions and an understanding of global requirements and ICH guidance
• Experience with manufacturing, process development, quality control, or quality assurance
• Experience with leading a team and training and managing staff
• Experience in Veeva Vault platforms