Title: Associate - Regulatory Affairs

Job status: Full Time

Location: Hyderabad

Overview:

We are looking for a detail-oriented and proactive Regulatory Affairs Associate with 35 years of relevant experience in pharmaceutical Regulatory Affairs. The candidate must have hands-on experience and knowledge of regulatory requirements in major regulated markets, including those of the US FDA, European Union, and/or Health Canada.

The role will primarily support Health Canada regulatory activities, including dossier preparation, submissions, post-approval activities, regulatory responses, and coordination with cross-functional teams. The candidate will work closely with senior Regulatory Affairs team members across multiple projects.

Role & responsibilities

- Support preparation, compilation, formatting, and review of regulatory dossiers and submission documents for Health Canada.
- Compile documents and information received from different functions and ensure completeness and consistency.
- Support eCTD / dossier publishing and submission-related activities, as applicable.
- Support multiple regulatory projects and stakeholders, prioritizing activities based on project requirements and team priorities.
- Maintain regulatory trackers, submission status,



commitments, approvals and related records and follow up on pending actions and deliverables.
- Support preparation of responses to regulatory queries and requests under the guidance of senior Regulatory team members.
- Assist senior team members with regulatory research and review of applicable guidelines.
- Perform other Regulatory Affairs and administrative activities as assigned.

Preferred candidate profile

- Bachelors or masters degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
- 3–5 years of relevant Pharmaceutical Regulatory Affairs experience.
- Hands-on USFDA regulatory experience is mandatory.
- Exposure to other regulatory markets such as Health Canada or European Union will be an advantage.
- Working knowledge of eCTD compilation and submission processes.
- Exposure with regulatory deficiency/RFI responses and post-approval change management.
- Solid working knowledge of MS Office, particularly Word and Excel.
- Strong communication, coordination, documentation, and attention-to-detail skills.
- Ability to manage multiple projects, priorities, and timelines.

📌 Associate - Regulatory Affairs (Hyderabad)
🏢 Trianon Pharma India
📍 Hyderabad