Senior Director, Global Regulatory Affairs

Insmed, Inc. Bridgewater , NJ 08807

Posted 2 months ago

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.

See if you are a match!

See how well your resume matches up to this job - upload your resume now.

Find your dream job anywhere
with the LiveCareer app.
Download the
LiveCareer app and find
your dream job anywhere

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Associate Global Regulatory Affairs CMC


Posted Yesterday

VIEW JOBS 11/18/2018 12:00:00 AM 2019-02-16T00:00 Job Description This position will provide support for Chemistry Manufacturing and Controls (CMC RA) for licensed and clinical biological products. This position may provide input into the product strategy for commercial and clinical teams. Incumbent will be responsible for supporting the defined regulatory strategy which is aligned with Health Authority requirements from a global perspective and assuring regulatory submissions are on time and high quality. Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites, communication to senior management and our partners (including Quality and Supply Chain). Creates collaborative working relationships with Global Regulatory Affairs (GRA CMC &Devices, Regions and Country Regulatory Groups), Technical and Quality Groups within R&D and Industrial Affairs, External Alliance Partners, Project Direction/ Management (R&D Development, Innovation, Pharma Operations teams), Regulatory Health Authorities, Others Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required. Major Activities/Key Responsibilities * New applications for biologics: * Plan/Prep/Submit/Review support for product dossiers * CTA / IND preparation and maintenance * License Maintenance * Recurrent filings: (US, Canadian NDC and YBPR, license and renewals) * Site renewals (ex. Japan Accreditation) * Post Approval Supplements * Regulatory strategy development * Preparing / authoring / review of submissions per Sanofi way of working – US, EU and Rest of World (ROW) * Technical Review of site supporting specific documents (CoA, declarations, etc) * Notify GRA Ops for publishing and dispatch as required * Responses to Health Authority questions – US, EU and ROW * Interaction / liaise with FDA, EMA on CMC topics * Global Regulatory CMC Strategies and risk assessments for development projects and/or marketed products in collaboration with other parts of GRA * Assures positive and collaborative relationships with CMC teams to achieve implementation of appropriate regulatory strategies * Change Controls * Change control assessments * Initiate change in regulatory database and follow-up with local regulatory representatives on the assessments of the change. * Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations as required. Qualifications Basic Qualifications: * University degree in scientific discipline with 2- 5 years regulatory experience or equivalent experience * Knowledge FDA regulations is required * Experience with biological and/or small molecule products Preferred Skills: * Proficient in MS Word, Excel, PowerPoint, MS Project, and IT Systems * Excellent organizational, communication (written and verbal) and negotiation skills. * Analytical, accurate with an eye for detail * Demonstrated ability to work successfully on project teams. * Analyses possible solution using standard procedures * Previous experience working in a fast paced environment on multiple product lines * RAC certification preferred. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Apply For Role Sanofi Bridgewater NJ

Senior Director, Global Regulatory Affairs

Insmed, Inc.