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Regulatory Affairs Specialist - CMC/NDA/Clinicals

7.00 to 10.00 Years   Bangalore   12 Jun, 2023
Techno Science
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Responsibilities :- Plan, prepare, and submit high-quality files to health authorities for fast approvals- Work as an integrated part of global cross-functional teams with stakeholders from various departments- Prepare and deliver meeting packages to Health Authorities- Conduct Health Authority interactions and seek regulatory approvals globally- Demonstrate subject matter expertise in regulatory science and global Life Cycle Management activities.Key Duties:- Compile, review, and submit pre-meeting packages for authority meetings- Handle post-approvals, query responses, and change requests from Quality Assurance- Submit regulatory files, respond to health authorities, and maintain marketing authorizations worldwide- Manage Pharmacovigilance documentation, including Drug Safety Update Reports, Periodic Safety Update Reports, Investigation Brochures, Clinical Trial Reporting, and clinical trial applications- Handle Life Cycle Management (LCM) of the product, including maintaining clinical file protocols and interim study reportsQualifications:- 10+ years of experience in Regulatory Affairs, specifically in CMC/NDA/Clinicals- Graduate or postgraduate degree required- Experience in handling health authorities, government bodies, and local market authorities- Experience in life cycle management of products- Global exposure in handling different markets- Excellent communication and presentation skills- Bold and strong personality with proven negotiation skills- Self-managed with a strong personal drive- Team player with the ability to engage with colleagues and peers- High cultural sensitivity and comfortable working across different countries and time zones,

Keyskills :
documentationdatabase administrationdeliveryadobe creative suitefunctional

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