Regulatory Affairs Executive/Sr. Executive - EU/ROW Parenteral Dosage Formulations

Why This Role Matters
The Regulatory Affairs Executive/Sr. Executive – EU/ROW Parenteral Dosage Formulations at Jodas Expoim plays a critical role in ensuring timely regulatory approvals and compliance for parenteral products in European and Rest of World (ROW) markets. This role contributes to faster market access by preparing, reviewing, and finalizing high-quality dossiers in line with EU/ROW regulatory requirements. By ensuring adherence to applicable ICH and EMEA guidelines, this position supports the company’s mission of delivering safe, effective, and compliant pharmaceutical products to global patients.

Job Description
The role involves end-to-end responsibility for regulatory dossier preparation, technical review, and document finalization for parenteral dosage forms intended for EU and ROW submission. You will ensure that all submissions meet regulatory requirements and internal quality standards, contributing directly to the product lifecycle management. The role requires proactive engagement with cross-functional teams including Quality, R&D, Production, and QA to ensure completeness and accuracy of documentation while minimizing regulatory queries.

Key Features of the Role:
• Preparation and technical review of EU/ROW dossiers for parenteral dosage forms
• Ensure regulatory compliance throughout the product lifecycle
• Support Post-Approval Variations (PAVs) in EU/ROW and provide correct categorization decisions
• Collaborate with cross-functional teams to ensure high-quality documentation
• Contribute to global product submissions and accelerate approval timelines
• Maintain up-to-date knowledge of EU/ROW regulatory requirements, ICH, and EMEA guidelines
• Mentor and guide junior regulatory team members to maintain compliance and efficiency

Responsibilities:
Process / Operational:
• Independently review and prepare Modules 2 & 3 of EU/ROW dossiers for parenteral dosage forms
• Ensure completeness, accuracy, and compliance of technical documentation
• Apply sound knowledge of parenteral formulation development and general analytical aspects
• Assess post-approval variation requirements in EU/ROW and recommend appropriate regulatory actions
• Liaise with Quality Assurance to review related change controls and assess regulatory impact

Strategic:
• Manage multiple regulatory tasks and deadlines effectively
• Plan and execute assignments while adapting to changing organizational priorities
• Maintain high work quality and ensure timely submission of dossiers

People-Related:
• Exhibit a positive attitude toward work and colleagues
• Provide guidance to team members and support knowledge sharing
• Develop strong interpersonal skills to effectively collaborate with cross-functional teams

Basic Skills:
• Strong written and verbal communication skills
• Proficient in MS Office Suite and PDF management tools
• Attention to detail and ability to produce accurate regulatory documentation
• Ability to interpret and implement EU/ROW regulatory guidance and technical expectations

Required Qualifications:
• M. Pharm / B. Pharm degree
• 4–8 years of experience in regulatory affairs for pharmaceutical products
• Hands-on experience with EU/ROW regulatory submissions
• Strong understanding of parenteral dosage form development and analytical evaluation
• Experience with post-approval variations and regulatory compliance

Experience and Skills:
• Familiarity with ICH and EMEA regulatory guidelines
• Knowledge of pharmaceutical development and basic QA principles
• Ability to manage multiple priorities and deliver dossiers on time
• Proficiency in dossier preparation, technical document review, and submission coordination
• Strong analytical, organizational, and problem-solving skills

Salary Insights:
• Competitive and commensurate with experience

Number of Positions:
• 05 openings

Company Overview:
Jodas Expoim is a leading pharmaceutical company specializing in parenteral and oral solid dosage formulations with global regulatory footprints. The company emphasizes innovation, quality, and compliance, supporting products across EU and ROW markets. Jodas Expoim offers a collaborative environment where R&D, QA, and Regulatory teams work together to deliver high-quality medicines efficiently and safely.

FAQs:
• What is the required experience?
– 4–8 years in regulatory affairs for EU/ROW markets, preferably with hands-on dossier experience

• What qualification is required?
– M. Pharm or B. Pharm

• Which products will I focus on?
– Parenteral dosage forms

• Is knowledge of regulatory guidelines important?
– Yes, understanding ICH and EMEA guidelines is critical

• Will I need to handle post-approval variations?
– Yes, assessment and categorization of variations in EU/ROW are part of the role

Application Tips:
• Highlight EU/ROW regulatory dossier experience for parenteral products
• Emphasize knowledge of Modules 2 & 3, ICH, and EMEA guidelines
• Showcase ability to manage multiple priorities and meet submission deadlines
• Demonstrate experience with post-approval variation assessment and regulatory compliance
• Include experience in mentoring or guiding junior team members