RA Executive

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: B. Pharm / M. Pharm

Additional: Diploma in Regulatory Affairs is preferred

Experience: 4yrs to 8 Yrs of experience in Regulatory Affairs

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