Associate - Regulatory Affairs

• Manage and maintain regulatory data within the EMA Article 57 (A57) database.

• Ensure compliance with IDMP (Identification of Medicinal Products) standards and evolving regulatory requirements.

• Support the electronic submission of regulatory data to EMA (European Medicines Agency).

• Collaborate with cross-functional teams, including Regulatory Affairs, IT, and 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.

• 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.

• Experience with xEVMPD (Extended Eudravigilance Medicinal Product Dictionary).

• Knowledge of pharmaceutical regulatory affairs and lifecycle management.

• Experience with regulatory submission tools and databases.

Why Join Us?

• Work on high-impact regulatory projects in a global environment.

• Opportunity to develop expertise in IDMP compliance and data management.

• Collaborate with industry experts and enhance your regulatory knowledge.

If you are passionate about regulatory data management and ensuring compliance with evolving global standards, we encourage you to apply!