Regulatory Affairs Manager
at HealthCare Recruiters International

Date Posted: 11/25/2018

Job Description

Job Description: We are seeking an experienced Regulatory Affairs Associate, Scientist, or Manager to join our team. S/he will manage global regulatory strategy for early development for products in oncology and other serious diseases, and US and global strategy in collaboration with multiple stakeholders across the enterprise. Responsibilities 1. Manage assigned US Regulatory strategy for assigned products in Oncology and other serious diseases, accounting for company objectives and relevant guidance 2. Manage assigned projects and interactions with FDA and/or other global health authorities 3. Manage changes in the US regulatory environment and assist in assessment of impact on development and registration strategies 4. Build positive relationships with FDA and/or other global health authorities 5. Review, submit, and manage writing of dossiers for assigned products to health authorities 6. Manage interactions with Clinical and Technical teams during clinical development 7. Manage a collaborative team relationship across functional areas, including Clinical, Safety, Manufacturing, Pharmacology and Toxicology to drive early and late development 8. Work collaboratively with on-site Regulatory Operations for management of submission of dossiers, meeting packages, and special requests such as Orphan Drug Designation, Fast Track, Breakthrough Therapy or other requests to accelerate drug development 9. Coordinate interactions with junior staff supporting the program as assigned 10. Ensure quality and compliance in all activities Qualifications Bachelors and 3 years relevant industry experience including experience in Regulatory affairs Experience with IND/CTA and/or IDE/PMA/MAA/NDA/BLA submissions a plus Knowledge of interaction/negotiations with health authorities (e.g. FDA) Understanding of complex medical and scientific subject matter Understanding of regulatory submissions in eCTD format Excellent command of spoken and written English Sensitivity for multicultural/multinational environment and knowledge of the global pharmaceutical development process Demonstrated operational skills including planning, organizing and ability to motivate and manage work with other Participation as a team player on project teams, with an understanding of timelines for meeting deliverables and project requirements Medical device and/or CMC biologics experience a plus Good ethics, professional integrity, and personal values

Job Snapshot

  • Employee Type: Full-Time
  • Location: Princeton, NJ
  • Job Type: Management
  • Experience: Not Specified
  • Date Posted: 11/25/2018

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HCRI specializes in recruiting hard-to-fill and critical healthcare industry jobs that require expertise and insight to fill. Our mission is to help healthcare organizations and companies within the healthcare space to find the ideal professionals to help their business grow while providing an experience worthy of a referral.

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