Associate, Regulatory Affairs

About ClinChoice

ClinChoice partners with leading pharmaceutical, medical device, and consumer care innovators, providing expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology. Established in 1995, ClinChoice accelerates clinical trials with data-driven insights, delivers product registration strategies, and enhances patient safety through analyses. Their global delivery network includes centers in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines, supporting local and global regulatory compliance.

About the Role

Seeking an A57/IDMP Specialist to support regulatory data management and compliance with ISO Identification of Medicinal Products (IDMP) standards. This role involves managing EMA’s Article 57 (A57) database, ensuring data accuracy, and aligning regulatory submissions with IDMP requirements.

Key Responsibilities

• Manage and maintain regulatory data within the EMA Article 57 (A57) database.
• Ensure compliance with IDMP standards and evolving regulatory requirements.
• Support the electronic submission of regulatory data to EMA (European Medicines Agency).
• Collaborate with cross-functional teams (Regulatory Affairs, IT, Compliance) to ensure data consistency and integrity.
• Assist in the mapping and transformation of medicinal product data to meet IDMP standards.
• Monitor updates and changes to EMA’s IDMP implementation guidelines and ensure adherence.
• Provide data validation, quality control, and remediation as needed.
• Support EU shift operations, including data entry, review, and regulatory reporting.
• Coordinate with stakeholders to resolve data-related queries and discrepancies.
• If applicable, support remote operations based on client agreements.

Requirements & Tech Stack

• Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
• Experience in A57 database management and IDMP compliance.
• Knowledge of Regulatory Information Management Systems (RIMS) and structured data submissions.
• Familiarity with SPOR (Substance, Product, Organization, and Referential) data management.
• Strong understanding of EU regulatory requirements and EMA guidelines.
• Proficiency in data handling, validation, and quality control.
• Excellent communication and collaboration skills.
• Ability to work in EU shifts and support remote operations if required.

Preferred Qualifications

• Experience with xEVMPD (Extended Eudravigilance Medicinal Product Dictionary).
• Knowledge of pharmaceutical regulatory affairs and lifecycle management.
• Experience with regulatory submission tools and databases.