Job Title: Senior Associate Regulatory Affairs (JP9258) Location: Thousand Oaks, CA Employment Type: Contract Business unit:Regulatory TA Gen Med Duration: 18 months with likely extensions Job posting date: 10/05/2021 Note: Remote until COVID-19 restrictions are lifted, PST 8-5. Local Candidates only.
3 Key Consulting is hiring a Sr Associate Regulatory Affairs for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Background: strong with regulatory experience strong tech skills must be able to work in database systems. EPIC is a plus.
Experience (Preferred): • Database management experience • Regulated industry, science academia or clinical practice experience Job Summary: 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: 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): Master’s degreeOR Bachelor’s degree and 2 years of regulatory and/or drug development experience
Top Must have Skill Sets:
strong communication skills
regulatory or drug development background/experience
strong organizational skills
Day to Day Responsibilities:
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
Employee Value Proposition: Career growth opportunity, desire to explore career opportunity and learn from the ground up. Entry level role with room to move up the ladder. Ability to move to lead roles. Interview Process: Initial phone screen then phone interviews with others in the group. We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.