Senior Regulatory Affairs Consultant

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Position Overview: As a member of Parexel Regulatory GPL, you will lead regulatory consulting projects for pharmaceutical and biotechnology companies. As the primary point of contact for clients, you will be responsible for everything from project planning and execution to quality, schedule, and budget management, collaborating with internal and external stakeholders to lead projects to success. You will also contribute to client proposal activities and the generation of new business opportunities. Key Responsibilities: - Leading and managing regulatory consulting projects - Building client relationships and serving as the primary point of contact - Project planning, progress tracking, budgeting, quality management, and risk management - Collaboration and coordination with internal and external stakeholders - Providing strategic advice to clients and supporting problem-solving - Proposal drafting, scoping, and business development support - Mentoring and developing junior members Requirements: - Practical experience in the pharmaceutical, biotechnology, medical device, CRO, or consulting industry - Experience as a project leader or in project management - Client-facing and stakeholder management experience - Excellent problem-solving and communication skills - Business-level or higher English and Japanese proficiency (direct supervisor is located abroad) - Bachelor's degree or higher (science background preferred) Preferred Qualifications: - Experience in life science fields such as regulatory affairs, development, quality assurance, or medical affairs - Experience in consulting services - Experience participating in proposal activities or business development - Experience collaborating with international teams Highlights of this Position: - Opportunity to lead major projects for domestic and international pharmaceutical and biotechnology companies - Opportunity to interact directly with client executives and decision-makers - Gain broad experience in project management, consulting, and business development - Enhance expertise and leadership in a global environment Originally posted on Himalayas