Regulatory Affairs Associate I

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