About the role
Job Title: Associate – Regulatory Affairs
Employment Type: Contract, Full-time
Location: Chennai, India
Work Type: Office-based
Experience: 0–2 years
About ClinChoice
ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analyses.
Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.
We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.
We are seeking an experienced 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.
Required Qualifications & Skills
- 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.
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!