Position: Sr. Associate / Associate – Medical Writing (Drug Safety & Regulatory Affairs)
Company: DDReg Pharma Pvt. Ltd.
Qualification: Master’s degree in Pharmacology, Pharmacy, Medicine, or a related field (Advanced degree preferred)
Location: Gurgaon, Haryana, India
Experience: Minimum 3 years
Job Type: Full-time, On-site
Verified Job
Application Mode: Online
About the Company
DDReg Pharma Pvt. Ltd. is a global consulting firm specializing in Regulatory Affairs, Pharmacovigilance, and Medical Writing. With over a decade of experience, DDReg has built a strong reputation for helping pharmaceutical, biopharmaceutical, and medical device companies meet compliance standards and accelerate market access. Headquartered in Gurgaon, India, DDReg operates globally, offering end-to-end regulatory and safety documentation support. Medical Writing / Drug Safety / Regulatory Affairs Job
Job Overview
DDReg Pharma is looking for a Sr. Associate/Associate – Medical Writing (Drug Safety & Regulatory Affairs) to join its expert regulatory team in Gurgaon. This role involves preparing regulatory and safety documents to support global submissions, ensuring quality, accuracy, and compliance with international guidelines. Medical Writing / Drug Safety / Regulatory Affairs Job
This position is ideal for professionals with 3+ years of medical writing experience who are passionate about safety documentation, regulatory submissions, and scientific communication in the pharmaceutical industry. Medical Writing / Drug Safety / Regulatory Affairs Job
Key Responsibilities
- Medical Writing: Draft and review regulatory documents such as CTD modules, SmPCs, PIs, PILs, safety reports, and aggregate reports (PSUR, PBRER, PADER).
- Aggregate Reporting: Author and review periodic safety update reports; perform scientific assessments and ensure accuracy.
- Risk Management: Develop and author Risk Management Plans (RMPs) and Risk Evaluation & Mitigation Strategies (REMS).
- Regulatory Compliance: Ensure adherence to client-specific templates, formatting, and style guidelines.
- Safety Monitoring: Support ongoing review and management of safety information in collaboration with pharmacovigilance teams.
- Mentorship & Training: Guide junior writers, conduct training sessions, and create learning resources.
- Regulatory Intelligence: Perform research on global regulatory websites (e.g., US FDA, EMA, PMDA, TGA, MHRA) to track safety alerts and guideline updates.
- Medical Writing / Drug Safety / Regulatory Affairs Job
Required Qualifications & Skills
Education:
- Master’s degree in Pharmacology, Pharmacy, Medicine, or related life sciences discipline.
- Advanced or certified training in Medical Writing (e.g., AMWA, EMWA, RAC) is an added advantage.
Experience:
- Minimum 3 years in medical writing within the pharmaceutical or CRO environment.
Skills & Competencies:
- Strong grasp of regulatory and safety documentation.
- Excellent scientific writing and editing skills.
- Familiarity with global safety and regulatory submission standards.
- Proficiency in MS Office Suite and document management systems.
- Meticulous attention to detail and strong time management abilities.
Why Join DDReg Pharma?
- Professional Development: Participate in ongoing training and mentorship programs to advance your career.
- Collaborative Environment: Work alongside seasoned experts in regulatory affairs and medical safety.
- Career Growth: Defined pathways for advancement within the organization.
- Competitive Pay: Attractive compensation package based on skills and experience.
- Medical Writing / Drug Safety / Regulatory Affairs Job
Location
📍 Gurgaon, Haryana, India
🕒 Work Type: Full-time, On-site
How to Apply
Interested candidates can apply through the online application link provided below.
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