manager/sr.manager-compliance (regulatory affairs) - - gurgaon

posted
contact
randstad india
position type
temporary
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posted
location
gurgaon, haryana
function
Pharma, healthcare & lifesciences
position type
temporary
experience
7
reference number
53725
contact
randstad india

job description

manager/sr.manager-compliance (regulatory affairs) - - gurgaon

Company : Clinical Research CompanyLocation : GurgaonDesignation : Manager/Sr.Manager-Compliance (Regulatory Affairs)Experience : Minimum 7 yearsExposure in indian Regulatory Affairs & compliance & clinical trial operation KEY RESPONSIBILITIES • Manage and oversee development and approval of controlled documents of processes across Pharma and RWE offerings • Manage and oversee development and approval of controlled documents relatedto clinical study processes and systems including Policies, SOPs, WorkInstructions, forms, and templates in compliance with global regulatory standards • Execute strategy for role-based training curriculum, GCP training andInspection Readiness training for the Clinical organization • Ability to work with functional teams to flow out processes and developpreviously unwritten work instructions and/or development of New SOPs • Assistance with the preparation/collection of all training documents inpreparation for internal training file audit (e.g. completed SOP matrices, CVs, JDs etc.) • Oversee and/or conduct compliance assessments including but not limited to vendor/contractor qualification assessments • Manage and oversee the tracking of Suspected Serious Clinical Non-Compliance Issues (SSCNCI), including reporting (if applicable) and ensure follow-up andclosure • Manage the review of internal audit reports and collaborate with the Quality function(s) to assess process improvement and/or training needs andopportunities. • Execute plans with clinical teams and cross-functionally to prepare foraudits and regulatory agency inspections • Provide representation for the Clinical Compliance function in Sponsoraudits and Regulatory Agency inspections, and supervise Clinical preparation roomactivities • Manage follow-up within the Clinical organization on all audits, inspectionresponses, commitments, post-inspection activities, and implementation of Corrective and Preventive Actions (CAPA) Other • Develops plans for internal and external audits ensuring compliance withICMR, DCGI and MHFW guidelines for regulatory standards as well as company policies/procedures. • Directs and trains on Clinical Standard Operating Procedures and ClinicalOperating Procedures to ensure compliance with regulatory organizations. • Manages the clinical quality database of observations for quality analysisand assessment and identifies compliance risk. • Organizes pre- and post-study document reviews and takes corrective action. • Oversees technical document review and other good manufacturing practices activities in support of clinical development programs. • Provides leadership in continuous improvement of good clinical practices.

skills

indian regulatory, clinical trial operations