Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.
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.
Reporting to the Executive Director, Global Regulatory Affairs, this position will have overall responsibility for providing regulatory oversight & strategic technical regulatory input to cross-functional project teams for all project activities. Defines and implements global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for NAAs, JNDAs, NDS, NDAs and other regional submissions. This opportunity is located at our Bridgewater, NJ headquarters location.
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.
Assist in 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
Provide leadership and oversight for Regional Regulatory affiliates.
Coordinate with consultants and CROs assisting with submission activities, including preparing electronic submission documents
Creation and maintenance of Regulatory project logs/databases, tracking the submission status of reports and other Regulatory activities.
Bachelor's degree (scientific or clinical background desirable) required; advanced degree preferred.
Minimum 10 years Regulatory Affairs experience in the pharmaceutical or biotechnology required.
Must have experience in managing global marketing applications (e.g.MAA, JNA, NDS, and NDA) in electronic format (eCTD) submissions.
Experience in submission writing and review experience essential.
Experience with inhalation products would be a plus.
Must have experience of direct interaction with Regulatory Agencies, including EU and Asia Pac regions.
Experience with preparing submission-ready documents.
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.
Minimal travel (less than 10% of work time)may be required.
Must successfully exhibit Insmed's five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
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.