Associate, Regulatory Affairs
Clinchoice
Chennai0–2 yrs22m agovia Naukri
This job at a glance
- Who can apply
- Freshers and up to 2 years · Bachelor's degree or Master's degree
- Must know
- OperationsStakeholder management
- Work
- On-site in Chennai
- Pay
- Not stated by the employer.
- Skill demand
- Operations32%Stakeholder management32%of 99 similar fresher jobs posted in India this week
- Listed
- 3 Nov 2026 · still open
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About the Role
We are seeking an A57/IDMP Specialist to support regulatory data management and compliance with the ISO Identification of Medicinal Products (IDMP) standards. This role involves handling 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 (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.
Requirements & Tech Stack
- A57 database management
- IDMP compliance
- Regulatory Information Management Systems (RIMS)
- Structured data submissions
- SPOR (Substance, Product, Organization, and Referential) data management
- EU regulatory requirements
- EMA guidelines
- Data handling, validation, and quality control
- EU shifts
- Remote operations if required
Qualifications
- Bachelor's/Master's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Strong understanding of EU regulatory requirements and EMA guidelines.
- Excellent communication and collaboration skills.
- Experience with xEVMPD (Extended Eudravigilance Medicinal Product Dictionary).
- Knowledge of pharmaceutical regulatory affairs and lifecycle management.
- Experience with regulatory submission tools and databases.