Instagram
youtube
Facebook

Specialist - Regulatory Affairs Manager

5+ years
Not Disclosed
10 Feb. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

### **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!**