Regulatory Affairs- Nutraceuticals,vitamins

2 weeks ago

Mumbai, India Jayant Specialities Pvt. Ltd. Full time

**Preferred from Nutraceuticals Background**

**Preferred from Western Line of Mumbai**

**RESPONSIBILITIES & ACCOUNTABILITIES**
- Principle accountabilities are assisting in Regulatory Fillings.
- This involves, manageable knowledge on the regulatory and quality guidelines from various regulatory agencies FASSI (Nutraceuticals) ,ICH, FDA, EMA, Health Canada, ANVISA, PMDA, MFDS, CFDA etc.
- Strong knowledge on compilation of dossier and regulatory filling for ROW market, Japan, Europe and US/Canada as per requirement.
- Should have hands on experience on eCTD regulatory submission tools.
- Filling of regular amendments and annual updates to regulatory agencies. And complete life cycle management of existing filled products.
- Handling customer and regulatory queries as per requirement.
- Participation in the cross functional team meetings and providing regulatory inputs to the Product Development Teams.
- Liaisoning with various Govt. bodies and overseas partners for external interface and with Plant, RD, QC and Business Development for internal interface.
- Identifying the product quality issues, investigating the root causes and providing the technical solutions for compliance.
- Help in investigating regulatory complaints, customer market complaints, incidents, deviations, OOS, recalls and stability.
- Developing new procedures for various departments for strict compliance to GMP standards.
- Strong Knowledge on cGMP and ICH Guidelines.
- Representing during various regularity inspections (Local FDA, CDSCO, WHO, etc.).

**REQUIRED KNOWLEDGE AND EXPERIENCE (Job Specification)**:
**Education**: B. Pharm / M. Pharm

**Additional**: Diploma in Regulatory Affairs is preferred

**Experience**: 4yrs to 10 Yrs of experience in Regulatory Affairs

**IT Skills**: Should be familiar MS Office (Word, Excel & Power Point)

**Salary**: ₹360,000.00 - ₹500,000.00 per year

Schedule:

- Fixed shift

**Speak with the employer**
+91 7506726060

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