Manager Regulatory Affairs – Regulated Markets | Venus Remedies | Panchkula

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Job Overview

  • Date Posted
    April 13, 2023
  • Location (State / UT)
  • Expiration date
  • Experience
    8 Years, 13 Years
  • Gender
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Roles and Responsibilities:

Responsible for overseeing and ensuring compliance with all regulatory requirements for the development, approval, and marketing of pharmaceutical products.

  • Develop and implement regulatory strategies: works closely with the research and development team to develop and implement regulatory strategies for the approval of new drugs.
  • Ensure compliance with regulations: Ensures that the company is compliant with all applicable regulations and guidelines, including FDA regulations, international regulatory requirements.
  • Coordinate and prepare regulatory submissions: Responsible for coordinating and preparing regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and other regulatory filings.
  • Manage relationships with regulatory agencies: Establishes and maintains positive relationships with regulatory agencies.
  • Stay up-to-date with regulatory changes: Stays up-to-date with changes to regulations and guidelines, ensuring that the company remains compliant and that its regulatory strategies are updated accordingly.

Required Candidate profile

  • Should have experience in preparing and submitting regulatory dossiers, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
  • Should have exceptional attention to detail and the ability to ensure the accuracy and completeness of regulatory dossiers.
  • Should have strong project management skills and the ability to manage timelines and deliverables associated with the preparation and submission of regulatory dossiers.
  • Should have excellent written and verbal communication skills and the ability to effectively communicate with internal and external stakeholders regarding regulatory dossier preparation and submission.

Qualification: B.Pharma, M.Pharma