Associate - Regulatory Affairs

Trianon Pharma India; Hyderabad; Hybride; INR 500 000 - 900 000; Plein temps

Résumé du poste

Trianon Pharma India in Hyderabad is seeking an Associate - Regulatory Affairs to support Health Canada regulatory activities, dossier preparation, submissions, and post-approval activities under guidance of senior team members.

The ideal candidate has 3–5 years in pharmaceutical regulatory affairs, hands-on US FDA experience, and working knowledge of eCTD processes, with strong communication and documentation skills.

Qualifications

• Bachelor's or master's in pharmacy, pharmaceutical sciences, or related field.
• 3–5 years of regulatory affairs experience.
• Hands-on US FDA regulatory experience mandatory.
• Exposure to other markets such as Health Canada or EU advantageous.
• Working knowledge of MS Word and Excel.

Responsabilités

• Support preparation, compilation, formatting, and review of regulatory dossiers and submission documents for Health Canada.
• Compile documents from different functions to ensure completeness and consistency.
• Support eCTD / dossier publishing and submission-related activities.
• Prioritize activities across multiple regulatory projects based on requirements.
• Maintain regulatory trackers, submission status, commitments, approvals and related records.
• Assist with regulatory queries and responses under guidance of senior team members.
• Assist regulatory research and review of applicable guidelines.
• Perform other Regulatory Affairs and administrative activities.

Connaissances

US FDA regulatory

Regulatory submissions

eCTD knowledge

MS Office

Formation

Pharmacy degree

Pharmaceutical Sciences

Outils

MS Office

Description du poste

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.


• Strong 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.