lcm

lcm

Randstad
10-15 years
Not Specified

Job Description


job description
lcm in bengaluru
Participate as team member in a number of the company's projects, in aninternational Environment; • In the framework of post-approval life cycle projects: ✓ Assess change controls related to CMC changes; ✓ Participate to the definition and implementation of CMC regulatorystrategies for Quality Variations; ✓ Critically reviews technical documentation to be used for renewals andvariations; ✓ Write CMC part of renewal dossiers and variations packages worldwide (updateof module 2.3 and 3 sections, writing of the summary of changes including rationale for changesand current/proposed tables);• Participate to the definition and implementation of CMC regulatorystrategies for development and registration of innovative drugs; • Write, review and assemble high quality regulatory submissions, such asQuality Modules Marketing Authorization Applications (MAA/NDA), Investigational New Drug (IND/IMPD),briefing documents, etc.; • Provide advice on operational and technical CMC subjects (Manufacturing,analytical development, validation, specification setting, stability, etc.); • Provide support for the preparation of Agency meetings (EU and US); • Monitor, prioritize and supervise projects strategy, timelines, andmilestones and communicate them to the project team members; • Ensure compliance with regulations and applicable guidelines; • Stay up to date with CMC EU and US trends and requirements. \- Pre-Project/Business Development: • Represent CMC where relevant during meeting or calls with prospects • Participate in preparation of articles, conferences, webinar to providevisibility of the VCLS CMC activities Experience:• 10 to 15 years proven professional CMC experience (small molecules)preferably combining Life-Cycle- Management (Quality Variations / Renewals) across several markets worldwide;• Proven experience in critically reviewing detailed scientific CMCinformation; • Experience in the Pharmaceutical industry within a regulatory QA or QCenvironment is a plus; • Experience with Project Management is a plus. Personal attributes and skills: • Graduate in a scientific discipline (e.g. pharmacy, chemistry); • Excellent command of English (orally and in writing); • Strong written and verbal communication, presentation, and facilitationskills; • Strong problem-solving skills; • Demonstrated ability to manage and build relationships with colleagues andregulatory authorities; • Client- and business-oriented; • Proven ability to meet deadlines; • Ability to work across multiple projects and prioritize based on timelinesfor client deliverables; • Ability to juggle multiple priorities and adapt quickly to new situationsand new project demands; • Good command of MS Office (Word, Excel, PowerPoint) is required.
skills
LCM
qualification
B-Pharma, M-Pharma

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