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

Named Science’s Top Employer in 2021 and 2022

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 were named the No. 1 company to work for in the biopharma industry in Science’s Top Employers Survey for two years in a row.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview

Work with global submission teams to project, manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation through to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance’s and Insmed Operating procedures.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Work with global submission teams to project manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission through to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance’s and Insmed Operating procedures
• Work with Regulatory team to coordinate post initial submission activities in support of approval process, such as FDA Advisory Committee meetings, mock rehearsals, Oral Explanation meetings etc.
• Performs scenario planning when multiple regulatory strategies are being considered and proposes as necessary delivery strategies to achieve accelerated timelines
• In collaboration with contributing functional lines, creates and maintains a Global Submission Plan that captures detailed list of dossier content, key activities and timelines associated with delivery of the submission and associated anticipated approval dates
• Lead submission planning discussions with close collaboration with Regulatory team, ensuring team is aware of upcoming deliverables, aligned on roles and responsibilities, understands the interdependencies between submission activities and components, and that any issues, risks, or impact due to changes in strategy and/or timelines are assessed quickly throughout the submission process
• Must have and be able to utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays
• Hands-on experience coordinating and managing submission documents/components for simultaneous global regulatory submission projects in eCTD format [e.g., NDA/BLA/INDs, MAAs, JNDAs, etc.]
• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and coordinates internal review and approvals
• Responsible for understanding, adhering to, and advising others on global Regulatory Authority regulations and guidance associated with electronic submissions, which differ across regions and Regulatory Authorities
• Proven project management, organizational and time management skills to manage multiple ongoing projects simultaneously

Qualifications

• Bachelor’s Degree (advanced degree preferred) in life sciences or chemistry, with a minimum of 8 years of experience in regulatory affairs
• Project management experience in the pharmaceutical industry or in a regulatory environment, expertise with Microsoft Project and/or other project management tools
• Knowledge of Regulatory Affairs responsibilities from pre-IND through Phases I-IV Global / RoW Regulatory experience
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Excellent organizational skills, attention to detail and commitment to deliver high quality output
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams
• Advanced degree preferred, and significant industry experience 
• Software requirements: Veeva, Microsoft Project, Smartsheet, Microsoft Office

Travel Requirements

Up to X% travel, both domestic and/or international, with periods of 50% and more travel.

Salary Range

Insmed takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $175,000.00 to $241,667.00 per 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
• Competitive compensation package including bonus. 
• Stock options and RSU awards
• Employee stock purchase plan
• 401(k) plan with company match
• Professional Judgment Vacation Policy
• 11 paid holidays per year and Winter Break (typically between Christmas and New Year’s Day).

ADDITIONAL U.S. BENEFITS:

• Medical, dental, and vision plans
• Company-provided short- and long-term disability plans
• Company-provided life insurance
• Unique offerings of pet, legal, and supplemental life insurance
• Flexible spending accounts for medical and dependent care
• Accident and Hospital Indemnity plans
• Supplemental AD&D
• Employee Assistance Program (EAP)
• Mental Health on-line digital resource
• On-site, no-cost fitness center at our U.S. headquarters
• Paid time off to volunteer

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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.

Please note that we review every submission, and we will keep all submissions on file for six months.