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About Company

MakroCare is a leading provider of regulatory and clinical development solutions, based in Hyderabad, Telangana. We specialize in offering comprehensive services in clinical research, regulatory submissions, and scientific communication. Our team is dedicated to delivering high-quality, innovative solutions to support our clients in the pharmaceutical, biotechnology, and medical device industries.

Position Name :

Regulatory Affairs Specialist

Organization :



B.Pharm, M.Pharm, Msc, BSc, Lifesciences


4-8 years


CTC: 8.10 LPA



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:


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


  • 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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