Regulatory Affairs Executive Europe region (Injectables)

Job Summary:

We are seeking a Regulatory Affairs Specialist with 4 to 8 years of experience in compiling, preparing, and submitting regulatory dossiers in accordance with European regulations (EMA/EU). The ideal candidate will have a proven background in injectable drug products and will ensure regulatory compliance throughout the product lifecycle, working closely with cross-functional teams and regulatory agencies.

Key Responsibilities:

• Prepare, compile, and review regulatory submissions for the EU region, including CTA, MAA, Variations, Renewals, and PSURs/DSURs.
  
• Ensure dossiers comply with EMA and national regulatory authority requirements, including eCTD/NeeS formatting.
  
• Maintain product registrations and ensure timely submission of updates, renewals, and amendments.
  
• Liaise with internal departments (e.g., R&D, Quality, Clinical) to collect and verify data for regulatory submissions.
  
• Respond to queries from European regulatory agencies and prepare responses to deficiency letters.
  
• Monitor changes in EU regulatory requirements and assess the impact on products and documentation.
  
• Contribute to regulatory strategy development during all phases of the product lifecycle.
  
• Manage electronic submission tools and regulatory databases.
  
• Assist in audits and inspections to support compliance with regulatory expectations.
  

Required Qualifications:

• Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field.
  
• 4–8 years of hands-on experience in EU regulatory dossier preparation and submissions.
  
• Experience in regulatory submissions specifically for injectable drug products is mandatory.
  
• Strong knowledge of EMA guidelines, EU regulations (including 2001/83/EC and 2017/745 for medical devices if applicable).
  
• Experience with eCTD software and publishing tools.
  
• Understanding of regulatory procedures: CP, DCP, MRP, and national submissions.
  
• Excellent written and verbal communication skills.
  
• Strong project management and organizational abilities.
  

Preferred Skills:

• Experience in a CRO, pharmaceutical, or medical device company.
  
• Knowledge of regulatory requirements beyond the EU (e.g., UK MHRA, Swissmedic).
  
• Experience with regulatory intelligence tools and databases.