Regulatory Specialist (Pharmaceuticals)

Contract: Weston, Florida, US

Salary: $38.00 Per Hour

Job Code: 347981

End Date: 2024-05-08

Job Status: Expired

This Job is no longer accepting applications
Job Description:
 
The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs for distribution through the supply chain. Full track and trace will be achieved by:
  • Facilitating the electronic exchange of transaction information for each sale of prescription drugs.
  • Use and review product identifiers to verify products at the item level.
  • Improve the efficiency of recalls.
  • Support the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) to maintain Compliance.
Must Haves:
  • Bachelor’s degree (preferred), Associate Degree (required).
  • Must possess intermediate to proficient skillset in Excel when reviewing large data.
  • Written and oral communication skills via email and phone when presenting to internal and external stakeholders is a must.
  • Track record of strong communication, collaboration, and team-building skills; ability to connect with all levels of an organization. Ability to influence both internal and external stakeholders.
Responsibilities:
  • Acquire in-depth knowledge of the TraceLink system and sub-modules (training will be provided).
  • Collaborate with various levels of management, cross-functional teams, and external stakeholders.
  • Highly organized with the ability to manage, track and escalate (as needed) multiple tasks and activities.
  • Conduct testing with vendors, customers and serialization providers to ensure successful connectivity.
  • Excellent written and oral communication skills is a must; individual will be working directly with Anda customers and vendors via email or phone to coordinate the onboarding into the TraceLink application.
  • Support end users with issues related to the TraceLink application, EPCIS file errors, and sub-modules.
  • Perform all activities in compliance with the internal and external requirements/standards controls.
  • Perform activities such as computer work, preparing, investigating, researching, and analyzing data.
  • Perform related duties as assigned and may cross-train to support other Compliance activities.
Qualifications and Education:
  • Bachelor’s degree from an accredited college or university with (3) years of experience; or equivalent combination of education and related experience.
  • Full-time work experience related to pharmaceutical industry, supply chain management (distribution), regulatory affairs or equivalent education and experience.
  • Excellent communication, organizational, relationship management and analytical skills.
  • Diverse in utilizing variety of technical application systems (Tracelink, Smartsheet, Office Suite). Must possess intermediate to proficient skillset in Excel when reviewing large data.
  • Ability to muti-task, take initiative and prioritize in fast-paced Compliance environment to meet deadlines.
  • Good interpersonal and communication skills, with the ability to work independently and in collaborative team environment. Candidate must be able to strongly interact with all levels of organization and external audiences.
Job Requirement
  • Regulatory Affairs
  • TraceLink
  • Excel
  • Smartsheet
  • Drug Supply Chain
  • cGMP
  • Documentation
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Vishnu Nair
  • vishnu.nair@collabera.com
This Job is no longer accepting applications
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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