Job Title: Regulatory Affairs Senior Associate – (JP9258) Location: Thousand Oaks, CA. (Onsite) Employment Type: Contract Business Unit: Regulatory T.A. Gen Med Duration: 18+ months (with possible conversion to permanent) Posting Date: 10/06/2021
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: Core hours: 8-5 flexible depending on daily needs. 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.
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: client systems, processes and template documents; expectations and responsibilities of the US Regulatory Professional role; activities regarding the assigned programs, etc. Key Activities include:
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
Why is the Position Open? Supplement additional workload on team.
Top Must Have Skills:
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.
Master’s degree OR
Bachelor’s degree and 2 years of regulatory and/or drug development experience OR
Associate's degree and 6 years of regulatory and/or drug development experience OR
High school diploma and 8 years of regulatory and/or drug development experience
Strong communication skills - oral and written
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, engagements with this client are a great for experience.
Red Flags: No prior regulatory or drug development experience.
Video Skype Panel Interview.
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.