Regulatory Affairs - Executive- Pharma

Roles & Responsibilities:

1. Dossier Preparation and Submission:

Compile and review regulatory submissions in ACTD, CTD and formats.

Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements.

2. Review of Plant and R&D Data:

Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies.

3. Regulatory Compliance and Updates:

Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to maintain compliance.

Provide regulatory insights to internal teams on best practices for data management and documentation.

4. Documentation and Record Keeping:

Maintain well-organized records of submissions, communications, and approvals.

Use regulatory software and systems for document tracking, version control, and report generation.

Education:

Desirable Skills & Competencies:

• Attention to Detail: Ability to review and analyze technical documentation with precision.
• Collaboration: Effective communication skills for working with R&D, manufacturing, and quality assurance teams.
• Problem Solving: Proactive in identifying compliance issues and developing solutions to address regulatory challenges.
• Proficient in MS Office and regulatory documentation software.