Pharma Regulatory Analyst at Accenture – Apply Now!

Pharma Regulatory Analyst at Accenture – Apply Now!

Job Title: LifeScience Regulatory Services Analyst

Location: Bengaluru

Job ID: aioc-s01554092

Employment Type: Full-time

Company: Accenture

About Accenture

Accenture is a global leader in professional services, offering expertise in digital, cloud, and security solutions across over 40 industries. With 699,000 employees serving clients in 120+ countries, Accenture combines advanced technology with human ingenuity to drive innovation and deliver value. For more information, visit www.accenture.com.

Role Overview

As a LifeScience Regulatory Services Analyst, you will work within the Life Sciences R&D vertical, focusing on regulatory services. This role involves supporting biopharma companies by enabling better outcomes through regulatory compliance, scientific expertise, and patient-centric approaches.

Key Responsibilities

Regulatory Operations:

• Perform bookmarking and hyperlinking for submission components as per ICH guidelines and other health authority requirements.
• Review and transform source documents for submission.
• Conduct Quality Control (Document QC) checks for submission components.

Regulatory Compliance:

• Collect, collate, and evaluate scientific data for R&D.
• Provide guidance on legal and scientific regulations to ensure product compliance with current laws.
• Develop strategies for regulatory submissions and author CMC documents and health authority packages.

Collaboration and Reporting:

• Interact with peers for routine updates and escalate significant issues to supervisors.
• Work independently within a team with a focused scope of responsibilities.

Qualifications

Educational Requirements: Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).

Experience: 3 to 5 years of experience in regulatory affairs or related fields.

Skills and Competencies:

• Strong knowledge of regulatory affairs.
• Ability to manage tight deadlines and handle pressure effectively.
• Problem-solving and negotiation skills.
• Detail-oriented with a focus on quality.
• Familiarity with regulatory submission strategies and processes.

Work Environment

• Interaction primarily with peers; occasional exposure to clients and management.
• Moderate guidance for daily tasks; detailed instructions for new assignments.
• Role requires individual contribution within a collaborative team setting.
• May involve rotational shifts.