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.
Solid communication, coordination, documentation, and attention-to-detail skills.
Ability to manage multiple projects, priorities, and timelines.

📌 Associate Regulatory Affairs Hyderabad
🏢 Trianon Pharma India
📍 Hyderabad