Insmed Incorporated

Senior Director, Regulatory Affairs

Location US-NJ-Bridgewater
ID
2020-1325
Job Function
Regulatory Affairs

Company Description

About Insmed!

 

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

Overview

About the Role!

 

Overall responsibility for providing regulatory oversight & strategic technical regulatory input to cross-functional project teams for all Pipeline project activities. Defines and implements global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for INDs, IMPDs, MAAs, NDAs and other regional submissions.

  • This is a supervisory position with 1-2 direct reports
  • This role oversees vendors and/or contractors

Responsibilities

  • Formulate & implement Regulatory strategies and plans to achieve efficient & competitive product development
  • Provide regulatory direction for the coordination, and preparation of regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines
  • Provide regulatory input into cross-functional Project Teams for product development and submission activities
  • Act as regulatory lead for the review of documentation prepared by other technical functions
  • Provide regulatory review and approve of internal documentation supporting product development activities (e.g. clinical protocols, clinical study reports, statistical analysis plans, etc.)
  • Provide regulatory input into project teams as required to provide technical guidance & to assist in problem solving/issue resolution etc.
  • Lead cross-functional teams in Health Authority meetings
  • Participate and lead communications/negotiations with Regulatory Agencies
  • Act as primary contact for inquiries from regulatory agencies
  • Monitor the development of new requirements or regulatory procedures
  • Ensure on-time submission activities related to regulatory file maintenance
  • Eg. IND/CTA, information amendments, SAE reports, etc.
  • Coordinate with consultants and CROs assisting with submission activities, including preparing electronic submission documents
  • Ensure maintenance of regulatory project logs/databases, tracking the submission status of reports and other regulatory activities

Qualifications

About You!

  • Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred
  • Minimum 8 years Regulatory Affairs experience in the pharmaceutical or biotechnology required
  • Must have experience with managing submissions supporting marketing authorization applications (e.g. NDA, NDS and MAA) in electronic format (eCTD) submissions
  • Experience in submission writing and review experience essential
  • Experience in Orphan Designated disease development a plus
  • Must have experience of direct interaction with Regulatory Agencies
  • Experience with preparing submission-ready PDFs
  • Excellent organizational, planning, and follow-up skills.
  • Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
  • Strong interpersonal skills
  • Must have excellent communication skills (verbal and written).
  • Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat.
  • A bias towards action combined with high ethical standards is essential
  • Initiative, combined with a high energy level is critical to success
  • Must successfully exhibit Insmed’s five (5) core corporate values of: Respect, Passion Integrity, Collaboration, Accountability.
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Information

Travel Requirements:

  • Domestic and/or International travel required (less than 10%)

 

  • Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local 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. Insmed is an Equal Opportunity Employer.

 

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