Submission Specialist – Regulatory Affairs
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Industry: Pharmaceutical & Life Sciences
Department: Regulatory Operations
Experience Required: 0–2 Years
Education Required: Bachelor’s Degree (Science/Technology preferred)
Job Overview
We are seeking a detail-oriented Submission Specialist to support routine regulatory submissions to global Health Authorities. This role is ideal for early-career professionals looking to build expertise in regulatory submissions, eCTD compliance, and regulatory operations within a pharmaceutical R&D environment.
The Submission Specialist will be responsible for coordinating submission components, ensuring quality and compliance, maintaining regulatory systems, and supporting both US and international regulatory submission activities.
Key Responsibilities
Track, collect, and review submission components for routine regulatory submissions to Health Authorities
Coordinate with internal stakeholders to ensure submission documents meet quality and compliance standards
Troubleshoot issues within submission components and work with responsible teams for clarification or revision
Prepare submission documentation, including Cover Letters, FDA forms, and submission content plans
Perform submission verification to ensure eCTD compliance prior to and post-publishing
Update and maintain the Regulatory Information Management (RIM) system for planned and completed US submissions
Participate in submission team meetings as required
Coordinate non-eCTD submissions in collaboration with International Regulatory Team Leads
Support additional regulatory operational activities as assigned
Required Qualifications & Experience
Experience:
0–2 years of experience in the pharmaceutical, biotechnology, or life sciences industry
Exposure to regulatory submissions or regulatory operations is an advantage
Education:
Bachelor’s degree (BA/BS) in a science or technology-related discipline preferred
Key Skills & Competencies
Foundational knowledge of global regulatory practices, submission guidelines, and requirements
Understanding of the importance of timely issue resolution and escalation
Strong written and verbal communication skills in English, including communication with non-native English speakers
Basic presentation and documentation skills
Strong attention to detail with the ability to prioritize tasks effectively
Ability to execute non-complex projects independently
Critical thinking and problem-solving skills aligned with business and regulatory objectives
Stakeholder-focused mindset with the ability to understand workflows and priorities
Proficiency in desktop application software (e.g., MS Office)
Practical understanding of computer systems used in an R&D or regulatory environment
Why This Role Matters
This position offers hands-on exposure to regulatory submissions, Health Authority interactions, and compliance processes, making it an excellent foundation for a long-term career in Regulatory Affairs or Regulatory Operations within the global pharmaceutical industry.
Disclaimer
The above job description outlines the general nature and level of responsibilities assigned to this role. It is not intended to be an exhaustive list of duties or qualifications. Responsibilities may evolve based on organizational needs and business priorities.
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