Join Macleods Pharma Regulatory Team , Mumbai

Macleods Pharmaceuticals Recruitment Notification
  • Mumbai
  • ₹35000 INR / Month

Regulatory Affairs Officer, Executive at Macleods Pharma, Mumbai

Join the Dynamic Regulatory Affairs Team at Macleods PharmaMacleods Pharma, a leading global pharmaceutical company, is seeking a dedicated and experienced Regulatory Affairs Officer/Executive to join our team in Mumbai, Andheri. This full-time, on-site role offers the opportunity to be at the forefront of regulatory strategy and compliance, playing a pivotal role in the lifecycle management of our products across diverse markets.

Key Responsibilities:

  • Lifecycle Management: Oversee the entire product lifecycle for specific markets, ensuring all regulatory requirements are met.
  • Dossier Preparation: Compile and prepare comprehensive regulatory dossiers for submission to regulatory authorities.
  • Query Response: Address and respond to queries from regulatory bodies in a timely and effective manner.
  • Post-Approval Changes: Manage and document post-approval changes by regulatory guidelines.
  • Variation Filing: File variations and amendments to existing product registrations as required.
  • Cross-Functional Coordination: Work closely with cross-functional teams to facilitate regulatory processes.
  • Module 1-5 Expertise: Demonstrate proficiency in handling Modules 1–5 of regulatory submissions.
Macleods Pharmaceuticals Recruitment Notification
Macleods Pharmaceuticals Recruitment Notification

Candidate Profile:

  • Experience: 2–8 years of relevant experience in the Regulatory Affairs department, preferably with exposure to ROW, South Africa, MENA, and WHO markets.
  • Leadership Skills: Strong leadership capabilities to guide and influence project teams.
  • Communication Skills: Excellent communication and interpersonal skills are needed to effectively interact with internal and external stakeholders.
  • Problem-solving: exceptional problem-solving abilities to navigate complex regulatory challenges.
  • Analytical Skills: Have analytical skills to assess regulatory compliance and product documentation.
  • Industry Knowledge: In-depth understanding of pharmaceutical industry regulations and guidelines.
  • Technical Proficiency: Skilled in Microsoft Office Suite and project management tools.
  • Education: Bachelor’s or master’s degree in Pharmacy or a related field.

Apply Now: If you are ready to take on this challenging and rewarding role, we invite you to submit your updated CV to:

Join Macleods Pharma and contribute to our mission of providing high-quality, affordable, and innovative therapeutic solutions. We look forward to welcoming a new member to our regulatory team who shares our commitment to excellence and regulatory precision.

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