Director, Regulatory Labeling

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, 2022, and 2023

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 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.

  

 

Overview

This is a key role providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global Regulatory Labeling strategy for Insmed marketed and to-be-marketed products

Responsibilities

In close collaboration with Regulatory project leads in the US, EU, and Japan, the Director, Regulatory Labeling will be responsible for creating (and/or updating) labeling content, guiding internal review, and facilitating the approval process for labeling content for Insmed marketed and to-be-marketed products, including but not limited to:   

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

RA Labeling will 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: 

• be responsible for labeling strategy and labeling operations for Insmed marketed and to-be-marketed products 
• develop project timelines and manage all labeling projects from initiation to implementation 
• assess recently approved and/or comparable product labeling for applicability to Insmed labeling  
• ensure labeling is compliant with current regulations and guidances, and in line with internal SOP  
• chair Labeling Working Group meetings 
• represent labeling group on product sub teams, when applicable 
• be the primary contact with vendors (e.g., QC) as needed 
• participate in labeling meetings with Health Authorities, as necessary 

Position requirements:

• 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 
• Ability to work effectively with large cross-functional global teams 
• Excellent computer skills including high proficiency in MS Office and labeling management applications  
• Excellent verbal and written communications skills 
• Detail oriented 
• Excellent organizational and time management skills to manage multiple ongoing projects simultaneously

Travel Requirements

10%

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, 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 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.

 

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

 

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