Are you looking to advance your career in the pharmaceutical industry? Sun Pharmaceutical Industries Ltd is seeking a dedicated and detail-oriented Executive to join their team in Tandalja – R&D. This role offers a unique opportunity to work on critical projects, ensuring compliance and efficiency in dossier submissions for global markets. Below, we delve into the job description, responsibilities, and the skills required to excel in this position.
Job Description: Executive at Sun Pharmaceutical Industries Ltd
As an Executive at Sun Pharmaceutical Industries Ltd, you will play a pivotal role in the compilation, review, and submission of dossiers in the Common Technical Document (CTD) format. Your primary focus will be on ensuring the timely submission of dossiers and responses to deficiencies for the US, EU, and AUS markets. Additionally, you will be responsible for coordinating with cross-functional teams, reviewing R&D and plant documents, and compiling annual reports for the US market.
Key Responsibilities
- Dossier Compilation and Review
- Ensure the accurate compilation and review of dossiers in CTD format.
- Oversee the submission of dossiers and responses to deficiencies for the US, EU, and AUS markets.
- Document Review
- Review R&D and plant documents to ensure compliance with regulatory requirements.
- Query Evaluation and Response Preparation
- Evaluate queries from regulatory authorities and prepare comprehensive responses.
- Annual Report Compilation
- Compile and submit annual reports for the US market, ensuring accuracy and timeliness.
- Cross-Functional Coordination
- Collaborate with cross-functional teams to support development projects.
- Document Follow-Up and Tracking
- Track and follow up on documents from the plant and R&D to ensure timely submissions.
Skills and Qualifications
- Attention to Detail: Precision in dossier compilation and review is critical.
- Regulatory Knowledge: Familiarity with CTD format and regulatory requirements for US, EU, and AUS markets.
- Communication Skills: Strong written and verbal communication skills for query responses and cross-functional coordination.
- Organizational Skills: Ability to manage multiple tasks and meet deadlines.
- Team Collaboration: Experience working with cross-functional teams in a fast-paced environment.
Why Join Sun Pharmaceutical Industries Ltd?
Sun Pharmaceutical Industries Ltd is a global leader in the pharmaceutical industry, known for its commitment to innovation and excellence. By joining their team, you will have the opportunity to work on impactful projects, enhance your regulatory expertise, and contribute to the development of life-saving medications.
