The role focuses on preparing, reviewing, modifying, and submitting documents for the registration of respiratory products. The position also involves maintaining the life cycle of these products, updating the regulatory database, and supporting launches and ongoing commercial activities to meet the objectives of the regulatory affairs sub-function.

Key Accountabilities:

1. Regulatory Requirements and Strategy:
   • Assess region-specific regulatory requirements and perform gap analysis on registered dossiers. Develop and recommend regulatory strategies for product submissions to ensure compatibility with development activities.
2. Dossier Compilation and Submission:
   • Compile and review relevant registration information for respiratory products. Submit dossiers as required and compile responses to deficiencies, facilitating timely global approvals.
3. Product Launch Support:
   • Support the timely launch and commercialization of respiratory products and devices. Ensure cross-functional coordination and document reviews align with business timelines.
4. Regulatory Database Management:
   • Update and maintain the global registration database with the regulatory status of respiratory products, ensuring accurate and current records.
5. Post-Approval Life Cycle Management:
   • Contribute to life cycle management by closing change controls and submitting regulatory packages related to product changes and updates.
6. Portfolio Initiatives:
   • Assist in identifying leverage products and ensuring compliance with site transfer initiatives, contributing to the overall portfolio management.
7. Cross-Functional Participation:
   • Represent the respiratory team in meetings, including Control Tower, SAP, CIPDOX, and GOOSE, ensuring that the team’s interests are effectively communicated and managed.

Education Qualification:

• Bachelor’s or Master’s degree in Pharmacy.

Relevant Work Experience:

• 6 years of experience in regulatory filing, including compilation, submission, and approval. Strong knowledge of drug product development and respiratory products, particularly for US, EU, and international markets.

Competencies/Skills:

• Collaboration and teamwork
• Innovation and excellence in execution
• Accountability and performance management
• Empathy and leadership
• Agility and adaptability
• Strong domain knowledge in regulatory affairs
• People management skills

Job Location:

• Vikhroli, Maharashtra

Application Link