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Senior Director, Regulatory Affairs
Insmed San Diego, CA
$170k-231k (estimate)
Other 5 Months Ago
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Insmed is Hiring a Senior Director, Regulatory Affairs Near San Diego, CA

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 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 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

The Senior Director will be responsible for proposing and then implementing global regulatory strategy for Insmed gene therapy development stage product(s), providing input and guidance to cross-functional project teams.

May supervise one or more direct reports and will oversee vendors and/or contractors

This position will be located in Insmed’s San Diego, CA office.

Responsibilities

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

Additional representative responsibilities will include, but not necessarily be limited to, the following:• Propose and implement global regulatory strategic plans to facilitate efficient and competitive product development, documented via a Global Regulatory Strategy Plan• Play a key role in communications with FDA and with other Health Authorities (such as EMA and PMDA)• Provide regulatory input into cross-functional Global Project Teams for product development and submission activities• Provide regulatory input into project teams as required to provide technical guidance and assist in problem solving/issue resolution etc.• Provide regulatory review of documentation prepared by other technical functions supporting product development activities (e.g., clinical protocols, clinical study reports, statistical analysis plans, etc.)• Maintains existing INDs and all submissions thereto, providing direction for the coordination and preparation of submissions consistent with regulatory requirements to meet corporate strategy and timelines• Supervise the team responsible for IND/CTA submissions as assigned• Monitor the development of new requirements or regulatory procedures• In partnership with Regulatory Operations and/or third party service providers, ensure on-time submission activities related to regulatory file maintenance (e.g., IND/CTA, information amendments, SAE reports, etc.)• Coordinate with consultants and CROs assisting with submission activities

Qualifications

About You:

• Bachelors' degree required. Advanced degree - Master's/PhD/PharmD preferred• Minimum 12 years of Regulatory Affairs and/or relevant experience in the pharmaceutical or biotechnology industry• Experience with IND/CTA submissions and global registration applications (e.g., NDA, NDS and MAA)• Experience in direct interactions with Health Authorities• In-depth knowledge and application of US/international regulations, regional guidance documents and ICH guidance documents• Experience with electronic submissions (eCTD)• Regulatory writing and/or review of documents supporting product development and clinical trials• Strong interpersonal skills to collaborate effectively across multiple functional areas• Excellent written/verbal communication skills• 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• High ethical standards for compliance to regulations and procedures• Initiative, combined with a high energy level is critical to success• Must successfully exhibit Insmed’s five (5) core values of Collaboration, Accountability, Passion, Respect, Integrity• Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

Travel RequirementsMinimal travel.

Travel Requirements

Up to 5% travel.

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.

Job Summary

JOB TYPE

Other

SALARY

$170k-231k (estimate)

POST DATE

10/30/2022

EXPIRATION DATE

06/15/2023

WEBSITE

insmed.com

HEADQUARTERS

Bridgewater, NJ

SIZE

500 - 1,000

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