ClinChoice is inviting applications for the role of Associate – Regulatory Affairs in Chennai, India. This is a contract, full-time, office-based opportunity for candidates with 0-2 years of experience in regulatory data management, A57 database handling, and IDMP compliance.
Job Details
| Company | ClinChoice |
| Position | Associate – Regulatory Affairs |
| Department | Regulatory Affairs |
| Location | Chennai, India |
| Employment Type | Contract, Full-time |
| Work Type | Office-based |
| Experience | 0-2 Years |
Job Description
ClinChoice is seeking an experienced A57/IDMP Specialist to support regulatory data management and compliance with ISO Identification of Medicinal Products (IDMP) standards. The role involves handling EMA’s Article 57 (A57) database, ensuring data accuracy, and aligning regulatory submissions with IDMP requirements.
ClinChoice works with pharmaceutical, medical device, and consumer care innovators and provides expertise across clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology.
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.
Qualification
- 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.
Experience
Candidates should have 0-2 years of experience.
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.
How to Apply
Interested candidates can apply online through the official application link below.
