Cipla has been a leader in the pharmaceutical industry for decades, providing innovative solutions and accessible medications. Known for its commitment to quality and patient-centric healthcare, Cipla aims to improve the lives of millions globally. The company operates in over 80 countries and specializes in areas such as respiratory, oncology, and antiviral medications.

As part of Cipla’s Integrated Product Development (IPD) division, the Team Member – Regulatory Respiratory plays a critical role in ensuring regulatory compliance and facilitating product registrations globally.

Responsibilities in the Job

The responsibilities for this position are comprehensive and ensure regulatory compliance across regions:

1. Regulatory Requirement Analysis

• Check region-specific regulatory requirements.
• Perform gap analyses for registered dossiers and recommend regulatory strategies for submissions.

2. Dossier Compilation and Submission

• Compile and review respiratory product dossiers for global submissions.
• Prepare and submit responses to regulatory deficiencies to secure timely approvals.

3. Product Launches and Commercial Support

• Coordinate cross-functional efforts for timely product launches.
• Review documents to ensure adherence to timelines.

4. Regulatory Database Management

• Maintain and update the global registration database for respiratory products.

5. Lifecycle Management

• Manage post-approval activities, including compiling and submitting regulatory packages.
• Address change controls for lifecycle maintenance.

6. Portfolio and Initiative Support

• Evaluate data to identify leverage opportunities.
• Ensure compliance during site transfer initiatives.

7. Participation in Key Meetings

• Represent the respiratory team in Control Tower, SAP, CIPDOX, and GOOSE meetings.

Qualifications

To excel in this role, candidates must meet the following qualifications:

• Education: Bachelor’s or Master’s degree in Pharmacy.
• Experience:
  • Minimum of 6 years in regulatory filing, including compilation, submission, and approval processes.
  • Knowledge of drug product development and respiratory products for US, EU, and international markets.

Skills and Competencies

Cipla values a mix of technical expertise and soft skills to foster a collaborative and innovative environment. Key skills for this role include:

1. Technical Skills:
   • Strong domain knowledge in regulatory processes and respiratory products.
   • Familiarity with tools like SAP, CIPDOX, and GOOSE.
2. Core Competencies:
   • Collaborate to Succeed: Foster teamwork across departments.
   • Innovate to Excel: Drive innovation in regulatory processes.
   • Perform with Accountability: Maintain integrity and responsibility in work.
   • Lead with Empathy: Build supportive and inclusive work relationships.
   • Act with Agility: Adapt to changing regulatory requirements and priorities.
3. People Management:
   • Ability to lead teams and manage cross-functional collaboration effectively.

Application Link

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