Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Consistently Ranked Science 's Top Employer Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science 's Top Employers survey for four years in a row.A Certified Great Place to Work® We believe our company is truly special, and our employees agree. In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, PEOPLE® Companies That Care, Best Workplaces for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists. Overview This role focuses on the early stages of drug development, from pre-clinical through Phase 1 and Phase 2 clinical trials. Responsibilities will also include regulatory strategy development for drug development for rare diseases. Manager/ Sr. Manger, Regulatory Affairs will be the Regulatory Lead for providing technical regulatory input to cross-functional project teams for assigned early development project activities. This person will ensure that all regulatory requirements/commitments are met with respect to regulatory submissions, as well as coordinate with regional RA leads and CRO(s) to meet regulatory requirements in ex-US regions. Responsibilities Responsibilities (Essential Role Responsibilities): * Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management to define the Global Regulatory Strategy Plan * Provide regulatory input into cross-functional Global Product Teams for product development and submission activities * Responsible for the coordination and preparation of US regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines * Ensure all regulatory activities and submissions are thoroughly documented and compliant with applicable regulations and guidelines * Lead preparation for regulatory communications and meetings * Provide regulatory review and approve of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.) * Monitor the development of new regulatory requirements/ procedures * In partnership with Regulatory Operations, ensure on-time submission activities related to regulatory file maintenance e.g. IND/CTA, information amendments, safety reports, etc.) * Coordinate with consultants and CROs assisting with submission activities * Maintain US regulatory project logs, tracking the submission status of reports and other regulatory activities Position Requirements (Required and/or Preferred Skills, Experience and Education): * Bachelor's degree (scientific or clinical background desirable) required; advanced degree preferred * Minimum 5 years of the pharmaceutical or biotechnology industry required at least 3 years with Regulatory Affairs experience * Experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions * Experience with preparation and review of electronic format (eCTD) submissions * Direct interaction with FDA is preferred * Experience in submission writing and review experience are essential * Experience with Orphan Designation and/or Expedited Programs for Serious Conditions (Breakthrough Therapy Designation, Fast Track Designation, Priority Review Designation, Accelerated Approval) preferred * Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexiTo view the full job description, click here