We have vacancy for Assistant Manager - Regulatory Affairs, who have experience in pharmaceutical industry, Global clinical trials experience is mandatory.
Job location is Faridabad, Hybrid mode
Other industry candidates please avoid to apply.
Experience is mandatory, No freshers
Experienced candidate please share your resume to +91 (phone hidden) (Whatsapp )
Thara
Recruitment Consultant
SCH Search
Roles and Responsibilities
- Manage regulatory compliance for global clinical trials, ensuring adherence to ICH guidelines and local regulations.
- Coordinate with CROs (Contract Research Organizations) to ensure timely submission of documents and reports.
- Develop and maintain relationships with key stakeholders, including sponsors, CROs, and regulatory authorities.
- Provide technical support on eCTD structure and publishing requirements for global submissions.
- Ensure accurate tracking of document revisions and version control using tools like Documentum or similar systems.
Desired Candidate Profile
- 5-8 years of experience in Regulatory Affairs or related field (pharmaceutical industry).
- Bachelor's degree in Computers or relevant life sciences discipline; Master's degree preferred.
- Solid understanding of Global Clinical Trials GCP principles and regulations (e.g., FDA, EMA, MHRA).
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) with knowledge of electronic submission formats (eCTD).