Regulatory Affairs Associate I

3 weeks ago


Bengaluru, Karnataka, India Thepharmadaily Full time
Job Description

Assessment of Change Controls:

- Evaluate change controls for registration impact and ensure implementation of necessary dossier changes in Europe and International Markets.

Variations Compilation:

- Compile variation packages for products in the portfolio in collaboration with relevant stakeholders.

Regulatory Database Management:

- Manage regulatory databases and Trackwise system efficiently.

Experience and Qualifications: Qualifications:

- Academic degree with a chemical/pharmaceutical background.

Experience:

- 2-5 years of experience in CMC Regulatory Affairs, focusing mainly on Europe and International Markets.
- Proficient in registration procedures and pharmaceutical regulations.
- Familiarity with Document Management Systems.
- Strong prioritization skills and ability to adhere to timelines.
- Capable of working independently with moderate guidance.
- Problem-solving abilities and implementation of process improvements.
- Team player mentality.

Reporting Structure:Reports to Senior Manager CMC Regulatory Affairs

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