Senior Associate / Strategist - APAC CMC 1 ClinChoice

5.0 - 9.0 years

0 Lacs

karnataka

On-site

As a Regulatory Affairs Specialist, your role involves authoring regulatory submissions, ensuring compliance with regulatory bodies and International Council for Harmonisation (ICH) guidelines, collaborating with subject matter experts, maintaining document quality, managing timelines, identifying and communicating potential CMC Regulatory issues, and guiding teams on regulations and policies related to medicinal products. Key Responsibilities: - Author regulatory submissions, including CMC sections for NDAs and MAAs, and lifecycle maintenance filings. - Ensure regulatory compliance with regulatory bodies and ICH guidelines. - Collaborate with SMEs, scientists, QA, manufacturing teams, and r...

Posted 2 weeks ago

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Compliance Associate QIMA

2.0 - 6.0 years

0 Lacs

delhi

On-site

As a crucial member of the team at QIMA, your role will involve reviewing testing, audit, and inspection reports, drafting certificates of conformity, and coordinating with the technical team to ensure the trustworthiness of consumer products. Your expertise will be instrumental in safeguarding a diverse range of consumer goods, including clothes and electronics. Furthermore, you will have the opportunity to specialize in a specific field of product technical regulation and oversee orders and records for operations. Key Responsibilities: - Review testing, audit, and inspection reports while adhering to product standards - Draft and create certificates of conformity - Maintain accurate record...

Posted 1 month ago

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