Regulatory Affairs Manager - Formulations - Middle East/South East Asia/Africa Market

Regulatory Affairs Manager - Formulations - (Middle East/ South East Asia / Africa)

1. Regulatory submissions Emerging Market (Middle East/ South East Asia / Africa) and Query Response subsequently comply with applicable regulatory requirements.

2. Compile and review all required documents in accordance with the Relevant guidelines, Coordinate with relevant departments and prepare submissions.

3. Review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.

4. Draft and review Product Information & labeling as required.

5. Prepare version-controlled CMC writeup for the respective section.

6. Track Variation filings and approvals. Maintain database.

7. Perform registration compliance reviews against quality documentation.

Skills & Knowledge Required in Candidate

1. CMC Documents Review

2. Previous Experience with Emerging Markets - Filing and Query &Response

3. Experience with Lorenz DocuBridge or other eCTD software desired

4. Self-motivated, detail-oriented, and highly organized

5. Ability to collaborate and interact effectively with a variety of personnel

6. Excellent computer skills

7. Effective communication skills (written and verbal)

8. Proficiency in speaking, comprehending, reading, and writing English is required.