Regulatory Affairs

22 hours ago

Lucknow, Uttar Pradesh, India Clinforge Clinical Research Solutions Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 18,00,000 per year

Company Description

Clinforge Clinical Research Solutions Pvt. Ltd. is an emerging 
Contract Research Organization (CRO)
 dedicated to advancing excellence in 
scientific writing, regulatory documentation, and clinical research support services.

Headquartered in Lucknow, India, Clinforge operates at the intersection of 
education, research, and regulatory compliance
, serving as a bridge between academic innovation and industry implementation. With a focus on quality, ethics, and precision, Clinforge provides customized solutions to pharmaceutical, biotechnology, and academic partners seeking expertise in 
medical and scientific communication, clinical data documentation, and regulatory submissions.
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Role Description

Regulatory Documentation Standards

·       Align all medical/scientific writing with 
ICMJE, GPP3, and ICH E6 (R2)
.

·       Create internal SOPs for Manuscript Writing, Literature Review, and Publication Ethics.

·       Set up templates for CSR, IB, and CTD documentation (for future regulatory writing projects).

·  
Publication & Compliance Oversight

·       Ensure Clinforge's 
Journal of Drug Development & Clinical Research (JDDCR)
 follows COPE guidelines.

·       Support ISSN registration, peer-review documentation, and indexing compliance.

·  
Institutional Ethics & Audit Readiness

·       Prepare Clinforge for future CRO licensing by documenting SOPs and quality standards.

·       Liaise with consultants for registration under CDSCO / Institutional Bioethics Committee in future phase.

AICTE/PCI/UGC Alignment

·       Study guidelines for 
Skill Development Courses
, 
Value-Added Programs
, and 
Vocational Education
.

·       Draft frameworks for credit-based certification courses as per 
AICTE Model Curriculum for Pharmacy Education
.

·       Prepare documents for MoUs, add-on courses, and short-term program approvals.

·  
NAAC Compliance

·       Design documentation templates for colleges (Attendance, Feedback, Outcome Mapping).

·       Create a "CPA Compliance Handbook" that partner colleges can use during NAAC visits.

·       Map each CPA course with 
Learning Outcomes
 required under NAAC/NBA.

Qualifications

  • Experience in Regulatory Documentation and Dossier Preparation
  • In-depth understanding of Regulatory Requirements and Regulatory Compliance
  • Proven experience in Regulatory Affairs
  • Excellent written and verbal communication skills
  • Detail-oriented and highly organized
  • Ability to work independently and collaboratively
  • Advanced degree in a relevant field (e.g., life sciences, pharmacy, law) is a plus
  • Experience in the healthcare or pharmaceutical industry

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