Company Description Neoplus Translation & Neocubes Pharma are part of a global group (“The Neons”) focused on helping clients achieve their vision through specialized knowledge and expertise. Since 2012, Neoplus Translation has provided high-quality localization services across more than 140 languages, supported by an in-house team with strong capabilities in European, Middle Eastern, Asian, African, and rest-of-world languages.

Neocubes

Pharma, a subsidiary of Neoplus Translation, delivers tailored Regulatory and Pharmacovigilance services that support projects from early development through post-approval. The company manages dossier submissions and regulatory services across the EU, US, and other international markets, aligning with country-specific regulations.

Neocubes

Pharma operates with ISO 9001:15001 certification and a global network of qualified auditors, enabling robust GxP assistance for clients’ businesses.

Role Description This full-time, in office Senior Regulatory Affairs Associate role is based in the Greater Ahmedabad Area and focuses on the Canada market. The individual in this role will prepare, review, and manage regulatory documentation and submissions for Canadian health authorities, ensuring alignment with current regulatory requirements and guidelines.

Responsibilities include coordinating dossier compilation, maintaining up-to-date knowledge of Canadian regulatory frameworks, and supporting the development of regulatory strategies for new and existing products. The role involves collaborating with cross-functional teams (including pharmacovigilance, quality,



and translation units), responding to regulatory queries, and tracking submission timelines and approvals.

The Senior Regulatory Affairs

Associate will also contribute to continuous process improvements and support internal audits and compliance initiatives as needed.

Qualifications

- Strong skills in Regulatory Documentation, with experience drafting, reviewing, and managing technical and administrative regulatory files.
- Demonstrated expertise in Regulatory Compliance and Regulatory Requirements, particularly for Canadian market regulations and international standards.
- Hands-on experience with Regulatory Submissions, including preparation, coordination, and lifecycle management of dossiers to health authorities.
- Solid foundation in Regulatory Affairs, with the ability to interpret guidelines and advise internal teams on regulatory strategy and risk.
- Relevant degree in pharmacy, life sciences, regulatory affairs, or a related discipline.
- Experience in pharmaceutical, biotech, or healthcare regulatory environments, preferably with Canada market exposure.
- Strong analytical, organizational, and time-management skills, with attention to detail and accuracy.
- Effective written and verbal communication skills in English; ability to collaborate with cross-functional and international teams.
- Comfort working with documentation management tools, regulatory databases, and MS Office applications.
- Ability to work on-site in the Greater Ahmedabad Area and coordinate with global stakeholders across time zones.

📌 Senior Regulatory Affairs Associate-Canada Market (Ahmedabad)
🏢 Neoplus Translation u0026 Neocubes Pharma
📍 Ahmedabad