Are you an experienced Regulatory Affairs professional looking to take the next big step in your career? Strides Pharma Science Limited is currently hiring for its Bangalore location! This is an excellent opportunity for professionals with expertise in highly regulated markets such as Australia, Canada, Europe, and the UK. 🌍
If you have a strong foundation in CMC (Chemistry, Manufacturing, and Controls) and dossier management, this role offers a dynamic platform to showcase your skills and contribute to global healthcare innovation.
🧩 Role Overview: Regulatory Affairs (International Markets)
In this role, you will play a crucial part in the regulatory submission process, ensuring all documents comply with stringent global standards. From compiling applications to managing product life cycles, your contributions will directly impact the availability of quality medicines worldwide.
📌 Key Responsibilities & Scope of Work
📂 Dossier Compilation and Submission (M1 to M5)
- Compile and manage CTD (Common Technical Document) modules from Module 1 to Module 5
- Handle submissions for TGA (Australia), Health Canada, EMA (Europe), and MHRA (UK)
- Ensure accuracy, completeness, and compliance
🧪 Regulatory CMC Strategy
- Develop and execute CMC regulatory strategies
- Support Marketing Authorization Applications (MAA)
- Manage Post-Approval Changes (PACs)
📝 Deficiency Response Management
- Interpret and respond to regulatory deficiencies
- Ensure timely submissions to avoid approval delays
🔄 Life Cycle Management & Variations
- Manage product lifecycle activities
- Handle variations and post-approval updates
🤝 Cross-Functional Coordination
- Collaborate with internal teams for documentation
- Ensure technical accuracy and consistency
💻 eCTD Publishing & Software
- Perform electronic submissions using eCTD tools
- Ensure compliance with digital submission standards
✅ Training and Quality Review
- Support internal training initiatives
- Conduct detailed quality checks for submission readiness
🎯 Candidate Profile: Who Should Apply?
- Experience: 2–7 years in Regulatory Affairs
- Market Expertise: Australia, Canada, Europe, UK
- Technical Skills: CMC, CTD modules, eCTD publishing
- Education: B.Pharm / M.Pharm or Life Sciences
- Soft Skills: Attention to detail, deadline-driven, strong teamwork
🌟 Why Join Strides Pharma Science Limited?
- Global exposure to regulated markets
- Work in a structured, growth-oriented environment
- Be part of a company focused on Quality by Design
- Opportunity to grow within a leading pharma organization
Located in Bangalore, you’ll be working in one of India’s top pharmaceutical and tech hubs 🏢✨
📩 How to Apply
Ready to take the leap?
Send your updated CV to: Navya@arcolab.com
📌 Subject Line: Application for Regulatory Affairs – [Your Years of Experience]
