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Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

COD Research, a leading name in the clinical and contract research industry, specializes in delivering high-quality, compliant, and innovative solutions for regulatory submissions across global markets. Renowned for its expertise in regulated, semi-regulated, and ROW markets, COD Research is committed to excellence and precision. The company has a strong presence in Ahmedabad and is well-regarded for its employee-friendly policies and professional growth opportunities.

Key Responsibilities of a Regulatory Affairs Specialist

As a Regulatory Affairs Specialist, your primary responsibility will be to ensure regulatory compliance and successful submission of high-quality documentation for various markets, including the US, EU, and ROW. Key tasks include:

  1. Document Preparation and Management:
    • Development of regulatory documents like CTAs, IND/IMPD, MAA/BLA, and response documents.
    • Compilation of dossiers for regulated and semi-regulated markets.
  2. eCTD Publishing Support:
    • Support the deployment of tools for electronic Common Technical Document (eCTD) publishing.
    • Perform dossier gap analysis based on updated country-specific guidelines.
  3. Strategic CMC Oversight:
    • Lead and support Chemistry, Manufacturing, and Controls (CMC) aspects of dossiers.
    • Evaluate changes in CMC documentation and strategize filing categories.
    • Provide due diligence support for CMC strategies, especially for complex injectable products.
  4. Stakeholder Coordination:
    • Collaborate with internal and external stakeholders to ensure timely and high-quality submissions.
  5. Regulatory Meetings and Query Resolution:
    • Represent the organization in meetings with health authorities.
    • Address and resolve queries related to dossier assessments.

Qualifications for the Role

To be successful in this position, candidates must meet the following criteria:

  • Educational Background: A graduate or postgraduate degree in Pharmacy is mandatory.
  • Experience: A minimum of 3-6 years of experience in Regulatory Affairs, with a preference for expertise in the US and EU markets.
  • Preferred Skills:
    • Knowledge of CMC requirements for solid dosage forms and complex injectables.
    • Familiarity with eCTD publishing and country-specific guidelines.

Skills Required

  • Strong analytical and organizational abilities.
  • Exceptional communication and interpersonal skills.
  • Expertise in regulatory guidelines and submission standards.
  • Ability to manage multiple projects and meet tight deadlines.
  • Proficiency in addressing regulatory queries and performing gap analyses.

Application Link

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