Cipla Hiring Team Member – Regulatory Respiratory

Cipla Hiring Team Member – Regulatory Respiratory | Vikhroli, Maharashtra

Cipla, a global pharmaceutical leader, is currently seeking a Team Member – Regulatory Respiratory for their Vikhroli, Maharashtra office. This role is part of Cipla’s IPD department, focused on respiratory product registration and life cycle management. If you have experience in regulatory filings and product submissions for international markets, this opportunity offers a chance to contribute to Cipla’s mission of providing affordable healthcare worldwide.

Job Location

• Position: Team Member – Regulatory Respiratory
• Location: Vikhroli, Maharashtra, India
• Department: IPD (International Product Development)
• Employment Type: Permanent

Key Responsibilities

As a Team Member in the Regulatory Respiratory function, you will play a critical role in ensuring compliance with international regulations and facilitating timely product approvals. Your responsibilities include:

• Check region-wise regulatory requirements, perform gap analysis for registered dossiers, compile/recommend regulatory strategy for product submission to check leveragability, and to support development activities
• Compile respiratory product dossiers by collating and reviewing relevant registration information, submit dossiers as applicable, compile deficiency responses to facilitate timely approvals of respiratory products globally
• Support on-time launches and ongoing commercials of respiratory products and devices identified by the business plan through cross functional co-ordination and review of documents to ensure launch within timeline
• Update and provide the regulatory status of respiratory products for maintenance of the global registration database
• Manage post-approval life cycle management by contributing to the closure of change controls, by compiling and submitting regulatory packages, relevant to life cycle management to
• Support portfolio initiatives eg. identifying leverage products by evaluation of data, compliance with respect to site transfer initiatives to Participating in Control Tower, SAP, CIPDOX, GOOSE, meetings on behalf of respiratory team

Qualifications and Experience

• Education: Bachelor’s or Master’s degree in Pharmacy.
• Experience: A minimum of 6 years in regulatory filings, product submissions, and approvals for respiratory products, particularly for US/EU/International markets.
• Skills:
  • Strong knowledge of drug product development, especially for respiratory products.
  • Ability to collaborate with internal teams and regulatory authorities.
  • Proficiency in regulatory tools such as Control Tower, SAP, CIPDOX, and GOOSE.

Desired Competencies

Cipla is looking for a candidate with the following skills and values:

• Collaborate to Succeed
• Innovate to Excel
• Perform with Accountability
• Lead with Empathy
• Act with Agility
• Strong Domain Knowledge
• People Management

How to Apply

Interested candidates who meet the qualifications can apply directly via Cipla’s Careers Page.