Aizant Drug Research Solutions Pvt. Ltd., a leading contract research and development organization, is inviting applications for Regulatory Writing Executive positions at its Dulapally, Hyderabad facility. This opportunity is ideal for pharmacy graduates with 1–3 years of experience in clinical regulatory writing who are seeking to advance their careers in regulatory documentation, compliance, and submissions.
This role offers hands-on exposure to global regulatory standards, cross-functional collaboration, and high-impact clinical documentation aligned with ICH-GCP guidelines.
Job Details
- Company: Aizant Drug Research Solutions Pvt. Ltd.
- Location: Dulapally, Hyderabad, Telangana
- Experience Required: 1–3 Years
- Industry: Clinical Research / Regulatory Affairs
- Job Type: Full-Time, On-site
Key Responsibilities – Regulatory Writing
- Draft, review, and edit clinical study protocols, Investigator’s Brochures (IB), Informed Consent Forms (ICF), and Clinical Study Reports (CSR).
- Prepare and support regulatory submission documents including INDs, NDAs, CTDs, and briefing packages.
- Ensure documentation compliance with ICH-GCP, global regulatory requirements, and internal SOPs.
- Maintain consistency with approved templates, style guides, and document management systems.
- Collaborate with Clinical Research, Biostatistics, Regulatory Affairs, and Medical Affairs teams.
- Participate in project meetings and support delivery timelines.
Eligibility & Qualifications
- Education: B.Pharmacy / M.Pharmacy / PharmD
- Strong understanding of clinical research processes and regulatory requirements.
- Excellent written and verbal communication skills in English.
- Proficiency in Microsoft Office and document management systems.
Desired Skills & Competencies
- Experience with regulatory submissions to FDA, EMA, or other agencies.
- Familiarity with medical terminology and basic statistical concepts.
- Ability to adapt writing style for scientific, regulatory, and patient-facing documents.
- High attention to detail and commitment to data accuracy and compliance.
Why Join Aizant?
- Exposure to global regulatory projects and submissions.
- Structured work environment with strong quality and compliance culture.
- Career growth in regulatory writing and clinical research.
- Competitive compensation aligned with industry standards.
Estimated Salary: ₹4.0 – ₹7.0 LPA (based on experience and skills)
How to Apply
Interested and eligible candidates should email their updated CV to:
📩 sonyjeevitha.degala@aizant.com