Regulatory Affairs Associate

2 weeks ago

Mumbai Maharashtra, India Planet Science Full time

**About Us**:
An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO**

**Position
- Regulatory Affairs Associate.**

An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having experience and knowledge of handling technical queries and regulatory documentation.

**Responsibilities**:

- Handling entire regulatory documents of excipients.
- Resolving technical queries of big pharmaceutical clients
- Handling technical matters & document related work of excipient manufacturer.
- Preparation of in house technical documents, required for promotion of excipient products.
- Should be able to understand & provide specific technical documents, for manufacturer & product qualification.
- Regulatory qualification documents and queries for Excipients / in-actives,
- Co-ordination with Excipients / in-actives manufacturer overseas
- USP/EP/JP Monograph comparison for various excipients / in-actives
- Preparing documents of Pharmaceutical companies, w.r.t Excipients Qualification
- Handling Virtual Audits of Pharma Customers w.r.t Excipients Qualification
- Handling Vendor Qualification Process end to end for Excipients Raw Material Products.

**Skills required**:

- Good Technical Know-how, w.r.t Guidelines / GMP / Testing Methods (for Excipients)
- Vendor management experience
- Minimum 2 years of experience into similar role
- Remuneration and benefits will be best in industry. _

Contact
- 08655687715

**Job Types**: Full-time, Fresher

Pay: ₹300,000.00 - ₹500,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Application Question(s):

- are you available to join immediate?
- are you ok to work into client coordination role dealing in pharma products?

**Experience**:

- total work: 1 year (required)

Work Location: In person

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