ClinChoice is seeking candidates for the position of Associate – Regulatory Affairs in Chennai, India. This is a contract, full-time, office-based opportunity for candidates with 0–2 years of experience.
The job description focuses on regulatory data management, EMA Article 57 (A57) database operations, and compliance with Identification of Medicinal Products (IDMP) standards. Candidates with knowledge of pharmaceutical regulatory affairs, structured data submissions, and European Medicines Agency (EMA) requirements can explore this opportunity.
Job Details
| Particulars | Details |
|---|---|
| Company | ClinChoice |
| Job Role | Associate – Regulatory Affairs |
| Job Location | Chennai, India |
| Employment Type | Contract, Full-Time |
| Work Mode | Office-Based |
| Experience | 0–2 Years |
| Job Function | Regulatory Affairs |
| Key Focus Area | A57 Database and IDMP Compliance |
Position: Associate – Regulatory Affairs
The role involves managing regulatory product information, maintaining EMA Article 57 database records, supporting electronic regulatory data submissions, and ensuring compliance with IDMP standards.
The responsibilities also include data validation, quality control, medicinal product data mapping, and coordination with Regulatory Affairs, IT, and Compliance teams.
Key Responsibilities
- Manage and maintain regulatory data within the EMA Article 57 (A57) database.
- Ensure compliance with IDMP standards and evolving regulatory requirements.
- Support electronic regulatory data submissions to the European Medicines Agency (EMA).
- Collaborate with Regulatory Affairs, IT, and Compliance teams to maintain data consistency and integrity.
- Assist in mapping and transforming medicinal product data according to IDMP standards.
- Monitor updates to EMA’s IDMP implementation guidelines.
- Perform data validation, quality control, and data remediation.
- Support EU shift operations, including data entry, review, and regulatory reporting.
- Coordinate with stakeholders to resolve data-related queries and discrepancies.
- Support remote operations where applicable and based on client agreements.
Eligibility and Qualifications
Candidates should possess:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.
- Knowledge or experience in A57 database management and IDMP compliance.
- Understanding of EU regulatory requirements and EMA guidelines.
- Familiarity with Regulatory Information Management Systems (RIMS).
- Knowledge of structured regulatory data submissions.
Required Technical Skills
- A57 Database Management: Understanding of EMA Article 57 database operations.
- IDMP Compliance: Knowledge of Identification of Medicinal Products standards.
- RIMS: Familiarity with Regulatory Information Management Systems.
- SPOR Data Management: Knowledge of Substance, Product, Organization, and Referential data.
- Regulatory Data Validation: Ability to perform data validation, quality control, and remediation.
- EU Regulatory Knowledge: Understanding of European regulatory requirements and EMA guidelines.
- Communication Skills: Strong communication and stakeholder collaboration abilities.
- Shift Flexibility: Ability to work in EU shifts and support remote operations when required.
Preferred Qualifications
Candidates with the following additional experience or knowledge will be preferred:
- Experience with xEVMPD (Extended EudraVigilance Medicinal Product Dictionary).
- Knowledge of pharmaceutical regulatory affairs and product lifecycle management.
- Experience with regulatory submission tools and databases.
About ClinChoice
ClinChoice is a global partner to pharmaceutical, medical device, and consumer care companies. Established in 1995, the organization provides expertise across:
- Clinical Operations
- Biometrics
- Regulatory Affairs
- Pharmacovigilance
- Medical Affairs
- Toxicology
ClinChoice has delivery centers and offices across the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines.
Why Join ClinChoice?
According to the job description, the opportunity offers:
- Exposure to high-impact regulatory projects in a global environment.
- Opportunities to develop expertise in IDMP compliance and regulatory data management.
- Collaboration with industry experts.
- Opportunities to enhance pharmaceutical regulatory knowledge.
