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DDReg Pharma Pvt. Ltd.
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Senior Associate– API_RA

Senior Associate– API_RA

DDReg Pharma Pvt. Ltd.

4 years

0 Lacs

gurgaon haryana india

Posted:1 week ago| Platform:

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Skills Required

documentation analysis remediation qos consistency communication regulations combination training data interpretation negotiation presentation development management excel word powerpoint report collaborative zones strategy compliance strategies gcc controls

Work Mode

On-site

Job Type

Full Time

Job Description

CMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -API
Prepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
Demonstrate subject matter and area expertise.
Collaborate with internal and external clients,
Supporting and enabling effective and efficient communication that results in operational excellence.
Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies’ website.

Education & Experience

Master’s degree in Pharma, Msc Chemistry
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4 to 6 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities

Excellent technical data interpretation skills
Excellent interpersonal skills including problem solving
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global, regional, national and other document development guidelines
Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
Ability and desire to work in a team-oriented environment.
Excellent written and verbal communication skills
Highly proficient with Microsoft Word, PowerPoint and Excel.
Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
Possesses a collaborative, results-driven style.
Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other Requirements

As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location

Gurgaon, Haryana (INDIA)Related Blog Post
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Senior Associate– API_RA