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Job highlights

Work/Life Balance

Time management

Flexibility

Problem Solving

As a Regulatory Affairs Specialist at MakroCare, you will be responsible for managing and overseeing regulatory submissions and communications with drug regulatory authorities. This includes ensuring compliance with CMC, eCTD/CTD requirements, and staying abreast of regulatory changes in the US, UK, EU, and ROW (Rest of the World) markets. The ideal candidate will have a strong background in regulatory publishing and submission processes and will play a crucial role in maintaining the high standards of MakroCare’s regulatory operations.

Key Responsibilities:

  • Prepare and review regulatory submissions in compliance with CMC, eCTD/CTD requirements.
  • Ensure timely and accurate submissions to regulatory authorities in the US, UK, EU, and ROW markets.
  • Monitor and interpret regulatory requirements and guidelines.
  • Ensure compliance with all relevant regulatory standards and policies.
  • Expertly handle the publishing and submission of regulatory documents.
  • Manage and maintain submission tracking systems.
  • Develop and implement regulatory strategies to ensure successful registration and maintenance of products.
  • Liaise with regulatory authorities and provide strategic guidance on regulatory matters.
  • Work closely with cross-functional teams including R&D, Quality Assurance, and Clinical Development.
  • Provide regulatory support and guidance throughout the product lifecycle.
  • Maintain accurate and up-to-date regulatory documentation and records.
  • Prepare reports and documentation for internal and external audits.

Eligibility Criteria:

Education:

  • Bachelor’s or Master’s degree in Life Sciences, B Pharmacy, or M Pharmacy.

Experience:

  • 4-8 years of experience in Regulatory Affairs, specifically within the Healthcare, Clinical Research, Biotech, Biopharma, or Medical Device industries.
  • Extensive experience with CMC, eCTD/CTD requirements.
  • Proven expertise in regulatory publishing and submission processes.
  • Strong understanding of regulatory requirements in the US, UK, EU, and ROW markets.

Skills And Abilities:

  • Strong analytical and problem-solving skills.
  • Excellent written and oral communication skills.
  • Detail-oriented with a strong focus on compliance and quality.
  • Ability to manage multiple projects and deadlines.
  • Proficiency in regulatory submission software and tools.

Application Link

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