“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- strong communication skills
- regulatory or drug development background/experience
- strong organizational skills
- supporting US Regulatory Lead in preparation for submissions to the US FDA
- supporting Global Regulatory Lead in preparation and facilitation of Global Regulatory Team meetings
- communicating with Publishing group in preparation for FDA submissions.
Background: strong with regulatory experience strong tech skills must be able to work in database systems. EPIC is a plus.
Database management experience
Regulated industry, science academia or clinical practice experience
The US Regulatory Professional, under the direction of a US Regulatory Lead, will assist in the creation and submission of regulatory documents and may be the US regulatory lead for a program under the supervision of a more experienced regulatory lead.
In the initial weeks of employment in this role, there will be onboarding training available from fellow US Regulatory Professionals and other staff members to familiarize the new hire with the following: this company systems, processes and template documents; expectations and responsibilities of the US Regulatory Professional role; activities regarding the assigned programs, etc.
- Assist US Regulatory Lead to support regional regulatory activities (e.g. dossier development and submission, advisory committee meeting preparations)
- Provide and maintain Clinical Trial Application (IND) and Marketing Application (NDA and/or BLA) documentation support (e.g. annual reports, amendments) in collaboration with US Regulatory Lead
- Create and maintain product regulatory history documents through IMR database and appropriately archive all regulatory documents and agency communications
- Review US regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance with submissions to regulatory agencies (FDA)
- Collaborate to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in Global Regulatory Team (GRT) to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare cross-reference letters to support investigator initiated studies
- Complete regulatory forms to support agency communications (e.g. FDA form 1571)
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals
Education and Experience (Basic)
Bachelor’s degree and 2 years of regulatory and/or drug development experience
Associate's degree and 6 years of regulatory and/or drug development experience
High school diploma and 8 years of regulatory and/or drug development experience
Knowledge and Skills
Strong communication skills - oral and written
"This posting is for Contingent Worker, not an FTE"