Cipla Hiring B.Pharm, M.Pharm in Maharashtra as Team Member in Regulatory Respiratory

Team Member – Regulatory Respiratory | Job Opportunity in Vikhroli, Maharashtra

Company Introduction

A leading division within the IPD sector, this organization is at the forefront of respiratory product development and regulatory affairs. With a global presence, it focuses on ensuring the compliance, registration, and successful market entry of respiratory products in various regions, including the US, EU, and international markets. The company is committed to innovation, excellence, and accountability in bringing cutting-edge respiratory products to market.

Job Responsibilities

As a Team Member – Regulatory Respiratory, the primary responsibilities include:

1. Regulatory Strategy & Dossier Compilation:
   • Analyze region-wise regulatory requirements, perform gap analysis on registered dossiers, and recommend regulatory strategies for product submissions.
   • Compile respiratory product dossiers, ensuring timely and accurate submission for global approvals.
2. Product Launch Support:
   • Collaborate with cross-functional teams to ensure on-time launches of respiratory products and devices, in line with business objectives.
   • Ensure ongoing commercialization and regulatory compliance for these products.
3. Life Cycle Management:
   • Oversee the post-approval lifecycle, including managing regulatory packages, submitting change controls, and ensuring product compliance.
   • Participate in meetings related to respiratory product management, utilizing tools like SAP, CIPDOX, and GOOSE.
4. Database Maintenance:
   • Update and maintain the regulatory status of respiratory products within the global registration database to ensure seamless product lifecycle tracking.

Educational Qualifications

The role requires a Bachelor’s or Master’s degree in Pharmacy, ensuring a strong foundation in regulatory filing and product development processes for respiratory products.

Relevant Work Experience

Candidates should have at least 6 years of experience in regulatory filings, compilation, submission, and approval processes, with specific knowledge of respiratory products, especially for the US, EU, and international markets.

Skills & Competencies

1. Strong Domain Knowledge:
   • In-depth knowledge of regulatory requirements and drug product development for respiratory products is crucial.
2. Collaboration & Communication:
   • Ability to work cross-functionally and communicate effectively to support product launches and ongoing operations.
3. People Management:
   • Demonstrated leadership and people management skills to ensure effective teamwork and regulatory compliance.
4. Innovation & Accountability:
   • A focus on innovation and the ability to take accountability for timely project delivery and regulatory approvals.

How to Apply

If you’re an experienced regulatory affairs professional with expertise in respiratory products, this is an excellent opportunity to advance your career. Interested candidates can apply directly through the company’s official career portal by searching for Req Id: 88102

Application Link