Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Trainee Regulatory Associate

Novartis
Novartis
0-5 years
Not Disclosed
10 July 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Trainee Regulatory Associate

We are seeking a Trainee Regulatory Associate to join our expanding team in Colombia. This role offers an exciting opportunity to gain hands-on experience in regulatory operations and publishing.

Core Responsibilities:

  • Publishing Support:

    • Document Management: Manage end-to-end publishing for initial IND/NDA/MAA applications and life cycle maintenance of global submissions.
    • Document Preparation: Collaborate with various departments to plan, prepare, and publish submission documents, including formatting, hyperlinking, and processing MS Word and Adobe Acrobat documents.
  • Compliance and Quality Control:

    • Regulatory Knowledge: Support the development of submission-ready documents and maintain up-to-date knowledge of agency standards and procedures for regulatory submissions.
    • Submission Formats: Support eCTD, NeES/eSub, and Paper submission formats for global agencies.
    • Quality Checks: Perform quality checks on published outputs to ensure compliance with regulatory standards and resolve any issues before submission.
  • Technical Support:

    • Troubleshooting: Address document issues with Adobe Acrobat and MS Word, and resolve gaps in submissions by collaborating with client stakeholders.
    • System Management: Review and interpret data to establish necessary systems/tools in line with SOPs and business processes. Perform data entry and quality control tasks as needed.
  • Training and Support:

    • On-the-Job Training: Provide training to beginners and colleagues, and offer QC feedback for continuous improvement.
    • Team Support: Support global/local team members with data management tasks and coordinate ancillary requests.
  • Project Management:

    • Coordination: Manage multiple requests simultaneously, ensuring deadlines are met and action dates are maintained.
    • Client Liaison: Liaise with suppliers, obtain required ancillaries/samples, and ensure timely delivery of documents to clients.

Desirable Skills and Experience:

  • Technical Proficiency: Proficient in MS Word, MS Excel, MS Access, MS PowerPoint, and Adobe Professional.
  • Attention to Detail: Strong accuracy and attention to detail in document preparation and quality control.
  • Communication Skills: Effective communication skills for liaising with internal teams and external stakeholders.
  • Problem-Solving: Ability to troubleshoot issues and provide solutions.
  • Organizational Skills: Strong project management skills with the ability to handle multiple tasks and meet deadlines.
  • Regulatory Knowledge: Understanding of regulatory processes and compliance standards.

This role is ideal for a proactive and detail-oriented individual eager to start a career in regulatory affairs and publishing.