Senior Manager, Regulatory Affairs

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, flexible, and a self-starter Computer proficiency with MS Office Suite programs, Adobe Acrobat, and Veeva Vault Strong interpersonal skills to collaborate effectively across multiple functional areas Excellent communication skills (verbal and written) Highly organized with a strong attention to detail, clarity, accuracy and conciseness Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat. A bias towards action combined with high ethical standards is essential Initiative, combined with a high energy level is critical to success Must successfully exhibit Insmed's five (5) core corporate values of: Collaboration Accountability, Passion, Respect and Integrity; along with any other position specific competencies Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace Supervision of Others: This is a non-supervisory position This role will oversee vendors and/or contractors Travel: Domestic and/or International travel required - less than 10%. Salary Range $119,000 - $167,267 a year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work, regionally based Competitive compensation package including bonus Stock options and RSU awards Employee Stock Purchase Plan (ESPP) Flexible Vacation Policy Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS: 401(k) plan with company match Medical, dental, and vision plans Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance Company-provided short and long-term disability benefits Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity insurance Employee Assistance Program (EAP) Mental Health on-line digital resource Well-being reimbursement Paid leave benefits for new parents Paid time off to volunteer On-site, no-cost fitness center at our U.S. headquarters Additional Information Insmed Incorporated is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information or any other characteristic protected by law. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewardsinsmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement. Applications are accepted for 5 calendar days from the date posted or until the position is filled. LI-JK