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.
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