Pharmalex hiring for experienced professionals in CMC, Regulatory Affairs.

Location: Noida/Mumbai

Experience: 6-8 Years

Experience Required: Europe Market

Please find the job description below.

➡️Health agency coordination, module 1 compilation, Response to queries during EU procedures. - CMC Evaluation, preparation and compilation of documents and sections regarding pharmaceutical quality. This includes documents for Investigational Medicinal Product Dossier and Quality Overall Summaries/Expert Reports for human medicinal products as part of the compilation of the marketing authorization dossier. Strong emphasis on relevant technical and regulatory requirements and customer specific demands.

➡️Gap analysis of the documents based on requirement - Regulatory support to the client for the desired product throughout lifecycle management of products

➡️Project management covering the quality, timelines

and customer satisfaction of the project - Coordination and communication with project teams, customers, other internal departments, suppliers, local partners and regulatory bodies, for all essential operational procedures.

➡️Graduate/Post-graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees

➡️Autonomous, concentrated and high-quality work

➡️Ability to work in a team

➡️Sense of responsibility with good organizational and communication skills

➡️Very good command of English

➡️Sound knowledge of current, legal and regulatory requirements of Developed markets (Japan, USA and EU)

➡️Ability to manage and prioritize multiple tasks, especially during stringent timelines.

➡️High degree of social competence and willingness to work in a team, experience in virtual teams and in matrix organizations.

Interested candidates can send their resumes at swati.chhabra@pharmalex.com. 

If your experience matches our requirements, we will reach out for interviews.

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