Regulatory Affairs Director

1 week ago

Waltham, Massachusetts, United States Taylor Strategy Partners Full time
Job Title: Director, Regulatory Affairs Job Summary: We are seeking a highly experienced Director, Regulatory Affairs to lead our regulatory strategy and operations. As a key member of our team, you will be responsible for developing and implementing a consolidated regulatory strategy to secure and maintain market access for our products. Key Responsibilities: * Develop and implement global regulatory strategy for assigned projects, working closely with Regional Regulatory Affairs representatives and Regulatory CMC. * Represent the company and communicate on all regulatory issues involving the FDA and other regulatory health authorities for all products and businesses. * Lead global and/or regional regulatory teams on assigned projects, providing leadership and guidance to team members. * Develop and execute US regulatory strategy and contingencies for assigned projects, serving as the primary interface for FDA. * Responsible for the review and approval of Standard Operating Procedures (SOP) relating to preparation, submission, and reporting information to regulatory authorities. * Prepare, plan, and implement new processes and policies to improve efficiency of the company. * Communicate project regulatory strategies and plans to management, cross-functional teams, and partners/collaborators to establish alignment. * Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risk. * Lead the preparation of submissions, including INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. * Prepare company teams for FDA and other health agency meetings, as required. * Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. Requirements: * Bachelor's degree in a scientific discipline; advanced scientific degree preferred. * Regulatory Affairs Certification highly desirable. * 10+ years pharmaceutical industry experience, including 7+ years in Regulatory Affairs leadership roles; global experience desired. * Experience in multiple phases of development in various therapeutic areas. * Demonstrated experience in preparing FDA submissions. * Knowledge of the drug development process and global submission process. * Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. * Inter-dependent partnering skills, team-oriented, and ability to influence outcomes are necessary skills in this environment. * Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously. * Must be able to innovate, analyze, and solve problems with minimal supervision and attention to detail. Company Overview: Taylor Strategy Partners is a leading consulting firm specializing in regulatory affairs and strategy. We work with pharmaceutical and biotechnology companies to develop and implement effective regulatory strategies that drive business success. What We Offer: * Competitive salary and benefits package. * Opportunity to work with a dynamic and experienced team. * Professional development and growth opportunities. * Remote work options available. How to Apply: If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your resume and cover letter to [insert contact information].

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