Regulatory Affairs Associate

☞ Teva Pharma

Ver: 106

Dia de atualização: 15-05-2024

Localização: Navi Mumbai Maharashtra

Categoria: Farmacêutico / Representantes farmacêuticos Impressão / Publicação Ciência Labor

Indústria:

Salário: ₹20,000 - ₹40,000 a month

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Conteúdo do emprego

· Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.

· Exposure in handling initial submissions publishing and transmitting quality submissions to agency.

· Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.

· Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.

· Hands on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.

· Participate in Global Regulatory Affairs project.

· Maintain working knowledge of internal and external publishing standards.

· Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)

· Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator

· Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems

Job Type: Regular / Permanent

Salary: ₹20,000.00 - ₹40,000.00 per month

Benefits:

  • Health insurance

Schedule:

  • Day shift

Supplemental pay types:

  • Yearly bonus

Ability to commute/relocate:

  • Navi Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required)

Experience:

  • total work: 1 year (Preferred)

  • Health insurance
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Data limite: 29-06-2024

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