Regulatory Affairs Associate
Newark Metro Area, NJ
Contribute to the development and implementation of global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
Contribute to the development and execution of US regulatory strategy and contingencies for assigned projects.
Participate on regulatory sub-team(s) for assigned projects.
Support the preparation of submissions, which may include INDs, Meeting Requests, Meeting Packages, Orphan Drug Applications, Breakthrough Therapy Designation Applications, Pediatric Study Plans, Marketing Applications including NDAs and BLAs, etc.
Work with cross-functional teams to define contributions to submissions.
Participate on regulatory submission teams for assigned projects.
Assist with preparation of eCTD Modules 1, 2 and 5 documents.
Assist with preparing project/study team for regulatory health agency meetings for assigned projects.
Represent Regulatory Affairs on various cross-functional teams such as study teams for assigned projects.
Apply knowledge of global competitive landscape, regulatory environment, regulations and guidances for assigned projects.
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures and departmental initiatives as assigned.
Perform QC of Regulatory components of TMF for assigned projects.
Bachelors degree in scientific discipline; advanced scientific degree preferred.
Experience in multiple phases of development in various therapeutic areas. Experience in oncology and/or hematology diseases a plus.
A minimum of 7 years pharmaceutical industry with a minimum of 5 years in regulatory affairs. Global experience a plus.
Thorough knowledge of the drug development process, with a focus on IND, NDA and BLA processes.
Demonstrated experience in preparing new IND, NDA and/or BLA submissions.
Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for attention to detail.
Commitment to delivering exceptional results, treating others with dignity and respect and sharing a passion for doing what is right for patients.
Domestic travel may be necessary.