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.
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Macleods Pharmaceuticals Recruitment Notification[/caption]
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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