Responsibilities include, but are not limited to, the following:
- Work with Global Regulatory Lead and/or US Regulatory Lead, Regulatory Operations, and Submission Teams to implement plans for assigned projects to meet target timelines;
- Manage and/or lead the preparation of Regulatory submissions, which may include INDs, NDAs, Health Authority Meeting Requests, Briefing Documents, Orphan Drug Applications, Breakthrough Therapy Designation Applications, Requests for Special Protocol Assessment, etc;
- Work cross-functionally with submission team members to define and manage contributions to submissions to meet target timelines;
- Participate in or lead the regional Regulatory Subteam for assigned projects;
- Effectively communicate Regulatory project objectives and progress to functional management and Regulatory Subteam;
- Participate in and/or lead regulatory interactions with FDA for assigned projects;
- Participate as Regulatory representative on various cross-functional operational teams for assigned projects;
- Maintain and reinforce compliance with Company SOPs and Work practices;
- Provide Regulatory research and intelligence support for assigned projects;
- Maintain knowledge on the US Regulatory environment, regulations and guidances/guidelines;
- Become knowledgeable with relevant regulations and guidances/guidelines in the regions applicable to the assigned projects and planned regulatory submissions.

Skills/Knowledge Required:
- Bachelors degree in scientific discipline; Advanced scientific degree (eg, MS, PharmD, etc) preferred;
- Experience in multiple phases of drug development; Experience in Hematology/Oncology Drug Development a plus;
- 2-4 years pharmaceutical industry experience including at least 1 year of regulatory experience;
- Good operational understanding of the drug development process;
- Experience managing US Regulatory submissions and dossiers (eg, INDs; NDAs);
- Results driven, team-orientated with demonstrated effective interpersonal skills and the ability to influence outcomes are necessary skills to be successful in this position;
- Demonstrated effective verbal and written communication skills, project/time management skills and keen attention to detail are needed to manage multiple ongoing projects simultaneously;
- Must be able to analyze, innovate and solve problems with minimal supervision and keen attention to detail;
- Domestic and occasional International travel may be necessary.

Qualifications
Prerequisites:
Bachelors in scientific discipline; 2-4 years pharmaceutical industry experience including at least one year of regulatory experience; Advanced degree in scientific discipline preferred.