4.0 - 8.0 years

0 Lacs

haryana

On-site

The job involves reviewing technical documentation for regulatory filings in various markets such as EU, UK, and US, specifically focusing on Gap Analysis and Remediation for module 3 -API. You will be responsible for preparing and compiling Section 322, QOS & QbR to ensure they comply with regulatory guidelines and meet the highest quality standards. It is important to critically review documentation for internal consistency and adherence to relevant guidelines to uphold regulatory excellence. Your expertise in the subject matter and area is crucial, along with collaborating with internal and external clients. Effective communication is key to achieving operational excellence. You should possess a high level of knowledge of country regulations and regulatory guidelines, staying updated with changes on various agencies" websites. Candidates are required to have a Masters degree in Pharma or Msc Chemistry, along with 4 to 6 years of relevant experience. Strong technical data interpretation skills, interpersonal skills, and negotiation skills are essential. Excellent oral and written communication skills, including strong presentation skills, are necessary. Proficiency in global, regional, national document development guidelines is required, along with good computer skills and the ability to work in a team-oriented environment. The role may require working in different time zones as needed. The position is based in Gurgaon, Haryana, India.,

Posted 4 days ago

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