### **Senior Specialist – Regulatory Project Manager | Bangalore, India**
**Job ID:** 279616 | **Location:** Bangalore, Karnataka | **Job Type:** Full-time
#### **Work Your Magic with Us!**
Join a global leader in **Healthcare, Life Science, and Electronics**, where regulatory expertise drives **innovation and compliance**. As a **Senior Specialist – Regulatory Project Manager**, you will oversee **global regulatory planning, submission tracking, and project execution**, ensuring **seamless compliance with health authorities worldwide**.
### **Your Role**
- **Regulatory Project Management & Strategy**
- Develop and execute **regulatory project plans** for major submissions (CTA/IND, MAA/NDA/BLA).
- Partner with **Global Regulatory Leads** and **Submission Managers** to align submission strategies.
- Ensure smooth **handover of planned submissions** to **Regulatory Operations**.
- Manage **submission task forces**, ensuring regulatory deliverables meet timelines.
- **Risk & Compliance Management**
- Identify and address **risks impacting submission timelines**.
- Maintain **risk registers** and ensure compliance with regulatory frameworks.
- Oversee **post-approval changes** and global regulatory procedures.
- **Stakeholder Collaboration & Leadership**
- Coordinate across **cross-functional teams** to streamline submission execution.
- Act as a key contact for **in-licensing/out-licensing deals**, ensuring **operational efficiency**.
- Maintain strong collaboration with **project controllers and global project management teams**.
- **Financial Oversight & Resource Planning**
- Support **budget forecasting** and track **actual project costs**.
- Manage **resource allocation for global regulatory projects**.
### **What You’ll Need**
- **Education:**
- **MSc or PhD** in **Life Sciences, Medical, PharmD, or a related field**.
- Advanced training in **Project & Portfolio Management** is a strong advantage.
- **Experience:**
- **8–14 years** in **pharmaceutical regulatory affairs, R&D, or regulatory project management**.
- Minimum **6–8 years** in **Regulatory Affairs or as a Regulatory Project Manager**.
- **Skills:**
- Expertise in **global regulatory submission procedures and compliance**.
- Proficiency with **RIM and EDMS RA applications**.
- Strong **leadership, project management, and stakeholder communication skills**.
### **What We Offer**
A collaborative and inclusive work culture where **you can lead, innovate, and grow**.
🚀 **Apply now and be part of our global regulatory team!**
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