{"id":3604652,"url":"https://alion.io/job/clinchoice-associate-regulatory-affairs","title":"Associate - Regulatory Affairs","company":{"id":672996,"name":"ClinChoice","domain":"clinchoice.com","url":"https://alion.io/company/clinchoice","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":78,"open_postings":13,"ghost_share":0,"stale_share":0.846,"repost_share":0.077,"time_to_fill_p50_days":39,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Chennai, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-11-02T08:57:56Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T05:44:40Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Job Title: Associate - Regulatory Affairs \nEmployment Type: Contract, Full-time \nLocation: Chennai, India \nWork Type: Office-based \nExperience: 0-2 years \nAbout ClinChoice \nClinChoice 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. \nOur 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. \nWe have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. \nWe 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.\nKey Responsibilities:\nManage and maintain regulatory data within the EMA Article 57 (A57) database.\nEnsure compliance with IDMP (Identification of Medicinal Products) standards and evolving regulatory requirements.\nSupport the electronic submission of regulatory data to EMA (European Medicines Agency).\nCollaborate with cross-functional teams, including Regulatory Affairs, IT, and Compliance, to ensure data consistency and integrity.\nAssist in the mapping and transformation of medicinal product data to meet IDMP standards.\nMonitor updates and changes to EMA’s IDMP implementation guidelines and ensure adherence.\nProvide data validation, quality control, and remediation as needed.\nSupport EU shift operations, including data entry, review, and regulatory reporting.\nCoordinate with stakeholders to resolve data-related queries and discrepancies.\nIf applicable, support remote operations based on client agreements.\nRequired Qualifications & Skills:\nBachelor’s/Master’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.\nExperience in A57 database management and IDMP compliance.\nKnowledge of Regulatory Information Management Systems (RIMS) and structured data submissions.\nFamiliarity with SPOR (Substance, Product, Organization, and Referential) data management.\nStrong understanding of EU regulatory requirements and EMA guidelines.\nProficiency in data handling, validation, and quality control.\nExcellent communication and collaboration skills.\nAbility to work in EU shifts and support remote operations if required.\nPreferred Qualifications:\nExperience with xEVMPD (Extended Eudravigilance Medicinal Product Dictionary).\nKnowledge of pharmaceutical regulatory affairs and lifecycle management.\nExperience with regulatory submission tools and databases.\nWhy Join Us?\nWork on high-impact regulatory projects in a global environment.\nOpportunity to develop expertise in IDMP compliance and data management.\nCollaborate with industry experts and enhance your regulatory knowledge.\nIf you are passionate about regulatory data management and ensuring compliance with evolving global standards, we encourage you to apply!","description_format":"text","description_chars":3559,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-11-02T11:12:00Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely 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