Company Description

Insmed is a growing global biopharmaceutical company powered by our purpose to deliver life-altering therapies to small patient populations experiencing big health problems. Our most valuable resource is our employees, and a patients-first mentality guides everything we do. Today, we are building a world-class team of talented individuals who are willing to challenge the status quo, solve problems, and work collaboratively and with a sense of urgency.

Come join us if you are ready to roll up your sleeves and be recognized for your efforts while working alongside team members who share your passion for serving patients and their families.

Recognitions

Named Science’s 2021 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 were named the No. 1 company to work for in the biopharma industry in Science’s 2021 Top Employers Survey.

A Certified Great Place to Work

We believe we have built something truly special at Insmed, and our employees agree. Each day, we show up for each other and for the patients we serve. That’s why we were recently certified as a Great Place to Work in the U.S.

Overview

The Regulatory Operations Associate will be responsible for functional activities related to global regulatory submissions. In addition, this individual will be responsible for general document management activities relating to the archiving of submission and submission related documents in the Company’s electronic document management system (EDMS).

Responsibilities

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

• Support global regulatory submission activities associated with generating electronic submissions
• Responsible for the archival of submission and submission related documents in the EDMS
• Contribute to submission planning in order to identify pending submissions and to define priorities
• Anticipate upcoming tasks based on the submission timelines
• Perform quality control checks and coordinate comment resolution with publishing team
• Support authors to complete regulatory documents such that all components are provided and presented in the correct format
• Manage document review and approval as needed
• Assists with other projects to support the regulatory department as assigned

Qualifications

About You:

• A minimum of 5-7 years of experience within the regulatory environment
• Proficient in Veeva RIM, WebTrader, InSight for Viewing, DXC Toolbox
• Effective/productive working with minimal supervision
• Knowledge of global electronic submission regulations
• Detail oriented
• Strong written and verbal communication skills
• Ability to multitask and prioritize when working on multiple projects, and deliver on tight timelines within a fast-paced team environment
• Flexible in handling shifting priorities

Travel Requirements

No travel required.

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.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TotalRewards@insmed.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.

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