Director, Regulatory Affairs
- 10 Finderne Ave, Bridgewater, NJ 08807, USA
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.
The Director, Regulatory Affairs has overall responsibility for providing technical regulatory input to cross-functional project teams for all project activities. Implements global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions (INDs, IMPDs, MAAs, NDAs) and other regional submissions.
- Formulate & implement Regulatory plans to achieve efficient & competitive product development, working with regulatory senior management to define regulatory strategies
- 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 in partnership with senior regulatory management as required to provide technical guidance & to assist in problem solving/issue resolution etc.
- Assist in communications with Regulatory Agencies
- May act as primary contact for inquiries from regulatory agencies
- Monitor the development of new requirements or regulatory procedures
- In partnership with Regulatory Operations, 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
- Creation and oversight for maintenance of regulatory project logs, 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 of Regulatory Affairs experience in the pharmaceutical or biotechnology industry required
- Must have experience with creating and managing INDs/CTAs, Annual reports/DSURs, and IND/CTA information amendment submissions. Experience supporting marketing authorization applications (e.g. NDA, NDS and MAA) a plus. Must have experience with electronic format (eCTD) submissions
- Experience in submission writing and review experience essential
- Experience with combination (drug/device) products a plus
- Experience of direct interaction with Regulatory Agencies also a plus
- Strong interpersonal and written/verbal communication skills essential
- Excellent organizational, planning, and follow-up skills. Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter
- Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired
- High ethical standards for compliance to regulations and procedures is essential
- Initiative, combined with a high energy level is critical to success
- 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.