: Regulatory Affairs Senior Associate - Licensing (JP8062)
Thousand Oaks, CA
RA CMC Regions & Sites
: 12 months with likely extensions
Job posting date
: 1 September 2020
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Regulatory Affairs Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Candidate will be working remotely during COVID then required to work on site, PST.
Sr. Associate Regulatory Affairs is responsible for:
- coordinating license renewals and handling government interactions germaine to U.S. Jurisdictional licensing.
- ensuring all State Manufacturer, Wholesale and Distributor licenses are maintained in accordance with State and Federal requirements.
- tracking and filing necessary applications.
Bachelor’s degree - 4 years of Regulatory experience within Pharma or Biotech. The person in this role must: Understand and complete State license application forms with relevant company and subsidiary information, be able to work independently, know how and where to find needed information.
Preferred: State wholesale and distributor license renewal procedures & Regulatory database procedures (huge plus)
Top Must have Skill Sets:
- Regulatory document management skills.
- General application management skills & strong computer aptitude.
- Attention to timeliness, details, and accuracy
Timely and accurate submission of license applications including:
Employee Value Proposition:
- monitoring state license renewal schedules.
- completing state license applications and renewal forms.
- obtaining signatures from Corporate Officers.
- liaising with licensing consultants.
- working in Company financial systems to request checks for state licensing fees.
- entering licensing information and filing licensing documentation into the regulatory document management system.
- maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
- Additional responsibilities may include supporting U.S. Regional Licensing Team with the following.
- Distribution Reports.
- Establishment Registrations.
Entree into regulatory, interesting interpretation regulation, broader impact through cross functional team, cross functional global network.
: short time at previous roles.
phone screen and then team phone interviews.
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.