Sr Executive -Regulatory Affairs-Europe (Formulations)

Department:

Role Summary

Quality/CMC (Module 3)

Key Responsibilities

1. Module 3 Preparation, Compilation & Review

• Prepare and review

  Module 3 (Quality / CMC)

  documentation (3.2.S and 3.2.P) in line with EMA/MHRA requirements.
• Ensure QOS (Quality Overall Summary – Module 2.3) aligns with Module 3 data.
  
• Review and consolidate documents such as PDR, MFR, stability data, process validation reports, batch analysis, control strategies, and specifications.
  

2. EU Dossier Submission (eCTD)

• Prepare and compile EU dossiers in full and hybrid applications (MAA), line extensions, and variations (Type IA/IB/II).
  
• Ensure high-quality, compliant eCTD submissions and lifecycle sequences.
  
• Collaborate with publishing teams for submission-ready dossiers.
  

3. CMC Change Management

• Manage post-approval changes (PACs) for European markets:
  
• variations (IA, IB, II)
  
• formulation changes
  
• site changes
  
• packaging changes
  
• stability / shelf-life updates
  
• Assess change impact based on EU guidelines (EMA, EC, CMDh).
  

4. Regulatory Query Responses

• Prepare and submit precise, scientifically justified responses to EMA, MHRA, and EU national authority queries.
  
• Coordinate with cross-functional teams for additional data requirements.
  

5. Stability, Analytical & Process Documentation

• Review stability protocols, trend data, analytical validation reports, and process validation documents.
  
• Ensure alignment of Module 3 content with GMP and ICH guidelines (ICH Q1–Q14 series).
  

6. Artwork / Labelling Support

• Review EU SmPC, PIL, and labelling for alignment with approved CMC data.
  
• Collaborate with labelling teams to ensure regulatory consistency.
  

7. Cross-functional Coordination

• Work closely with Quality Assurance, Formulation R&D, Analytical R&D, Production, and Packaging Development for data compilation.
  
• Provide regulatory guidance during scale-up, exhibit batches, and technology transfer.
  

8. Regulatory Intelligence

• Stay updated with evolving EU regulatory guidelines (EMA updates, CMDh templates, ICH changes).
  
• Communicate changes internally and implement compliance strategies.
  

Key Skills & Competencies

• Strong expertise in for EU submissions.
  
• Proficiency in

  eCTD compilation and lifecycle management

  .
• Knowledge of EMA, MHRA, ICH, and EU GMP regulatory requirements.
  
• Strong understanding of pharmaceutical manufacturing and analytical processes.
  
• Good communication, documentation, and scientific writing skills.
  
• Excellent coordination and time-management abilities.
  

Qualifications

• M. Pharm / B. Pharm / M.Sc. (Life Sciences)

• 4–8 years

  of experience in Regulatory Affairs (EU markets preferred).
• Hands-on experience in

  EU Module 3 creation and review

  is mandatory.

Regards

Team Jodas expoim