Sr Mgr Regulatory Affairs

Lets do this. Lets change the world. In this vital role you will provide leadership and oversight to the development of regulatory staff members in India as well as provide guidance on global regulatory requirements and CMC processes. This role involves management of staff and requires a strong understanding of the CMC regulatory requirements across countries, phases of development and indications for biologic, synthetic, and/or biosimilar products. This role also requires coordination with ROOTS2 management across Amgen sites to meet deliverables within tight timelines

• 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