Neoplus Translation & Neocubes Pharma
Website:
neocubespharma.com
Job details:
Company Description
Neoplus Translation and its subsidiary, Neocubes Pharma, are global leaders in translation, regulatory, and pharmacovigilance services. Since 2012, Neoplus Translation has specialized in localizing content for over 140 languages with expertise in European, Middle Eastern, Asian, and African languages. Neocubes Pharma provides tailored Regulatory and Pharmacovigilance solutions, supporting projects from early development to post-approval initiatives for clients across EU, US, and ROW countries. Equipped with ISO 9001:15001 certification and a global network of qualified auditors, we are committed to delivering comprehensive compliance, safety monitoring, and GxP assistance. Visit Neoplus Translation or Neocubes Pharma for more details.
Role Description
This is a full-time, on-site role located in Ahmedabad for a Regulatory Affairs Specialist focusing on Canada and the EU. The successful candidate will manage regulatory documentation, ensure regulatory compliance, and oversee submissions to meet global pharmaceutical requirements. Responsibilities include compiling, reviewing, and submitting regulatory documents in accordance with country-specific guidelines, providing support for audits, and staying up-to-date with regulatory changes impacting Canada and EU markets.
Qualifications
- Proficiency in Regulatory Documentation, including preparing, reviewing, and organizing dossiers
- Strong knowledge of Regulatory Requirements and Regulatory Compliance for Canada and EU
- Experience in Regulatory Affairs and ensuring submissions align with local and international standards
- Hands-on skills in managing Regulatory Submissions and liaising with regulatory agencies
- Familiarity with global pharmacovigilance practices and GxP standards is an advantage
- Bachelor’s degree or higher in Pharmacy, Chemistry, Life Sciences, or a related discipline
- Strong analytical, communication, and organizational skills with attention to detail
- Ability to work effectively on-site within a cross-functional team
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