Regulatory Affairs Assistant

5 days ago

Madurai, India Bitwise Solutions Full time

**Key Responsibilities**
- Develop in-depth (scientific and technical) product knowledge.
- General filing duties, stationary ordering and sorting of departmental post, assist with team travel arrangements, meeting organization and other administrative activities, raise and track purchase orders for all department activities, & log promotional copy review activities in local database.
- Submission of aggregate safety reports, Article 61(3) changes, Type IA and Type IB variations to MHRA/IMB, initiate post approval notifications and completion of associated activities & prepare Chemical and Pharmaceutical Datasheets and upload into global systems,
- Proof reading product information to ensure quality and accuracy & assist in product complaint sample management by co-ordinating shipping activities via DHL.
- Liaise with regulatory Health Authorities to clarify the status of regulatory submissions.

*

**Salary**: ₹25,000.00 - ₹85,000.00 per year

**Benefits**:

- Internet reimbursement
- Work from home

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Madurai, Tamil Nadu: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

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