Apply for Mitocon Regulatory Affairs PV Report Writing Specialist remote job in India. Check CTD writing skills, eligibility, and application details now.
Introduction
Professionals interested in regulatory affairs and pharmacovigilance writing can explore this excellent remote opportunity. This role focuses on preparing regulatory documents, CTD modules, and safety reports, making it ideal for candidates aiming to build expertise in global regulatory submissions and medical writing.
Company Overview
Mitocon Biopharma Pvt Ltd is a growing life sciences organization involved in regulatory, clinical, and pharmacovigilance services. The company focuses on delivering high-quality scientific and regulatory documentation while supporting global pharmaceutical and biotechnology projects.
Job Overview (Quick Details)
| Job Title | Regulatory Affairs & PV Report Writing Specialist |
|---|---|
| Company | Mitocon Biopharma Pvt Ltd |
| Location | Remote (India) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Pharmacovigilance |
| Experience Required | 1–5 Years |
| Education | B.Pharm, M.Pharm, Pharm.D, MSc, BSc |
| Salary | As per company norms |
Job Location & Employment Type
- Location: Remote (India)
- Employment Type: Full-time
- Work Mode: Work from home
Open Positions / Department Details
- Department: Regulatory Affairs & Pharmacovigilance
- Focus on CTD writing, regulatory documentation, and safety reports
- Work involves collaboration with cross-functional scientific teams
Key Roles & Responsibilities
Regulatory & PV Report Writing
- Prepare Health Hazard Reports for regulatory and pharmacovigilance purposes
- Draft clinical (CTD Modules 2.4, 2.5) and non-clinical (2.6, 2.7) documents
- Ensure high-quality scientific writing aligned with regulatory standards
Compliance & Documentation
- Maintain compliance with ICH, GCP, and pharmacovigilance guidelines
- Structure reports as per global regulatory requirements
- Ensure accuracy, consistency, and completeness in documentation
Data Analysis & Collaboration
- Work with internal teams to gather scientific and clinical data
- Ensure submission readiness of documents
- Coordinate with stakeholders for timely project delivery
Quality & Review
- Review regulatory documents for quality and compliance
- Maintain consistency across clinical and non-clinical reports
- Support continuous improvement in documentation processes
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in:
- Pharmacy (B.Pharm / M.Pharm / Pharm.D)
- Life Sciences (BSc / MSc)
- Clinical Research or related fields
Experience
- 1 to 5 years of experience in:
- Regulatory Affairs
- Pharmacovigilance writing
- Medical writing
- Experience in CTD module writing is essential
Skills Required
- Strong expertise in CTD Modules 2.4, 2.5, 2.6, 2.7
- Knowledge of regulatory guidelines (ICH, GCP, PV)
- Excellent scientific writing and documentation skills
- Strong attention to detail and quality control
- Good communication and coordination skills
- Ability to work independently in a remote setup
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- 100% remote work flexibility
- Exposure to global regulatory projects
- Opportunity to enhance medical writing expertise
- Collaborative and growth-oriented work environment
Selection Process
The hiring process may include:
- Resume screening
- HR discussion
- Technical assessment (writing skills)
- Final interview
How to Apply
- Interested candidates can apply via email or WhatsApp
Application Details:
- 📧 Email: sarvani.g@mitoconbiopharma.com
- 📱 WhatsApp: 80194 93434 (No weekend calls)
- 👤 Contact Person: Sarvani (Senior HR)
- Subject Line: Application – Regulatory Affairs & PV Report Writing Specialist
Important Dates
- Application Deadline: Not specified (apply early recommended)
Why Apply for This Pharma Job?
- Work remotely with a growing biopharma company
- Gain hands-on experience in CTD and regulatory submissions
- Build expertise in pharmacovigilance and medical writing
- Exposure to global regulatory standards
- Strong career growth in regulatory affairs domain
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Mitocon Biopharma Pvt Ltd or any recruiter. We do not charge any fees for job postings. Candidates are advised to verify job details before applying.
Final Call-to-Action
Eligible candidates with regulatory writing experience should apply immediately to take advantage of this remote opportunity in pharmacovigilance and regulatory affairs.
