Director, Regulatory Labeling
Insmed Incorporated

Job Info

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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 Biopharma TM List, Small and Medium, and one of the Best Workplaces in New York TM , which recognizes companies headquartered in NY, NJ, and CT.

Overview

This is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed and developmental products.

Responsibilities

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

In close collaboration with Regulatory project leads in US/EU/Japan, RA Labeling will be responsible for the creation (and/or updates) and internal review and approval process for labeling content for marketed product(s) and products in development, including but not limited to:

• CCDS
• prescribing information (e.g., USPI, SmPC, Japan PI)
• medication guides
• patient information/leaflet/IFU
• package labels

RA Labeling may also be responsible for:

• coordinating with multidiscipline team for US commercial implementation strategy
• providing labeling input for required postmarketing reporting
• managing dedicated labeling system
• maintaining appropriate labeling SOPs

In general, RA Labeling will:

• develop project timelines and manage labeling projects from initiation to completion.
• ensure labeling is compliant with regulations and guidances, and in line with internal SOPs for consistency across all Insmed labels.
• assess new regulations for impact on Insmed products.
• be the primary contact with vendors (e.g., QC) as needed.
• represent labeling group on product sub teams, when applicable.
• participate in labeling meetings with Health Authorities, as necessary.

Qualifications

• Bachelor's degree; advanced degree preferred
• 10+ years experience in the pharmaceutical industry, 7+ years of experience in global regulatory labeling
• Full understanding of the drug development process
• Knowledge of global labeling regulations and guidances
• Ability to analyze and solve problems
• Excellent computer skills including high proficiency in MS Office and labeling management applications
• Excellent verbal and written communications skills
• Excellent organizational and time management skills to manage multiple ongoing projects simultaneously

Travel Requirements

N/A

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

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.

This job has expired.