RA Executive

Inhalation Health Pvt Ltd

3 - 6 years

2 - 4 Lacs

goregaon

Posted:10 hours ago| Platform:

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Skills Required

regulatory affairs fassai ra drug regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Candidates should be from Nutraceuticals Background Or API Industry Only

preferred Female Candidate .

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, etc.
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.).

Education:

Additional:

Experience:

IT Skills:

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