Regulatory Affairs & Compliance Executive

Company Description

Contract Research Organization (CRO)

education, research, and regulatory compliance

Role Description

Regulatory Documentation Standards

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