### **Specialist – Regulatory Affairs Manager | Bangalore, India**
**Job ID:** 279902 | **Location:** Bangalore, Karnataka | **Job Type:** Full-time
#### **Work Your Magic with Us!**
Join a leading **Healthcare, Life Science, and Electronics** company where regulatory expertise drives **compliance and innovation**. As a **Specialist – Regulatory Affairs Manager**, you will manage **regulatory dossiers, lifecycle activities, and product compliance** to support **license security and market access**.
### **Your Role**
- **Regulatory Documentation & Compliance**
- Prepare and manage **regulatory dossiers** for new product applications and variations.
- Ensure **global compliance** with health authorities’ requirements.
- Interpret and implement **country-specific and international regulatory guidelines**.
- **Lifecycle Management & Strategy**
- Support **post-approval changes** and regulatory submissions in **at least two regions (e.g., Europe, USA, International)**.
- Maintain **regulatory documentation** in alignment with global procedures.
- Collaborate cross-functionally to **optimize license management strategies**.
- **Stakeholder Collaboration & Communication**
- Work within a **matrix organization**, engaging with key regulatory and business stakeholders.
- Proactively communicate potential **risks and challenges** to project timelines.
- Contribute to **regulatory intelligence** and best practices.
### **What You’ll Need**
- **Education:**
- Degree in **Life Sciences or related discipline (MSc preferred)**.
- **Experience:**
- **5+ years** in **pharmaceutical regulatory affairs, R&D, or academia**.
- **At least 1 year** of hands-on **Regulatory Affairs experience**.
- **Skills:**
- Strong understanding of **global regulatory procedures, post-approval changes, and dossier management**.
- Experience with **RIM, Vault, and EDMS RA applications**.
- Excellent **documentation, project management, and communication skills**.
### **What We Offer**
A collaborative and inclusive work environment where **you can grow, innovate, and lead**.
🚀 **Apply now and be part of our global regulatory team!**
Gujarat :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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