A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Regulatory Associate - Regulatory Submission Publisher
Job Description:
•Produces high-quality dossiers by handling the collection of components, publishing / assembly, quality review, and delivery of submissions in paper and electronic format. For paper submissions, creates cross-references, ta-bles of content, tab / slip sheets, and volumes. For electronic submissions, performs bookmarking, hyperlinking, and tables of content creation ac-cording to Health Authority (HA) guidelines.
•Publishes Regulatory documents with state-of-the-art software applications in the Novartis Development environment according to internal processes and agreed-upon timelines.
•Shares accountability with Regulatory Affairs Project Manager / Senior Pro-ject Manager and respective DRA Therapeutic Area / Business Unit man-ager(s) to ensure proper organization of a timely submission.
•Proactively troubleshoots technical/quality issues relating to the prepara-tion and dispatch of submissions. Liaise with counterpart and applicable line functions (e.g., DiT, Clinical) for problem solving (ensuring agreed upon action is implemented at the local destination).
•Performs technical quality control of published submissions before release to the HAs and / or Country Pharma Organizations (CPOs). This involves detailed verification of paper and / or electronic components to ensure compliance with HA regulations (e.g., checking all submission-level hyper-links / bookmarks to confirm accurate destinations).
•Support communication strategy within the Regulatory Global Services group India.
Support key processes are in place and functioning efficiently to facilitate teamwork and local communication
•Work within the Support systems and processes to enable accurate documentation and data in a validated environment
•Act cross-functionally locally to facilitate DRA Ops related agreements between line units
Candidate Profile:
- Tertiary qualified – Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
Experience:
- 0.5-1 years experience as an associate in regulatory affairs dealing with a wide variety of registration projects and issues.
Additional Information:
Experience: 0-1 years
Location: Hyderabad
Education: M.Pharm, M.Sc, B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Pharma
Business Unit: Pharma - Global Development
Job Type: Full Time
Employment Type: Permanent
Job ID: 101037BR
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