LifeScience Regulatory Services Associate
Location: Bengaluru, India
Company: Accenture
Employment Type: Full-Time
Experience Required: 1–3 years
Job ID: AIOC-S01634595
About Accenture
Accenture is a global professional services company with expertise in digital, cloud, and security. Serving clients across more than 40 industries, Accenture combines deep domain experience and specialized skills to deliver Strategy & Consulting, Technology & Operations services, and Accenture Song. With over 784,000 employees in more than 120 countries, we drive innovation, operational excellence, and transformative outcomes for clients worldwide.
Role Overview
The LifeScience Regulatory Services Associate will support Accenture’s Life Sciences R&D vertical, providing regulatory services to leading biopharma companies. This role ensures compliance with global regulatory requirements, supports electronic submissions, and manages essential documentation for regulatory filings. The associate will coordinate activities such as new application filings, Life Cycle Management submissions (CMC, amendments, annual reports, promotional materials), and SPL submissions, while maintaining compliance with international regulations.
Key Responsibilities
Manage and process electronic regulatory submissions, including original filings, amendments, and Life Cycle Management updates.
Coordinate essential documentation and resources required for global regulatory applications.
Provide regulatory guidance and support to clinical, pharmacovigilance, and R&D teams.
Ensure compliance with regulatory requirements and stay updated on changes in global regulatory frameworks.
Conduct routine problem-solving using established guidelines and precedents.
Support audit readiness and maintain documentation accuracy.
Collaborate with team members under supervision and provide timely updates on submission status.
May work in rotational shifts as required by project timelines.
Qualifications & Experience
Bachelor of Pharmacy (BPharm) or Master of Pharmacy (MPharm).
1–3 years of relevant experience in life sciences regulatory operations or pharmaceutical regulatory affairs.
Proficiency in English for international communication.
Knowledge of global regulatory requirements, electronic submission tools, and regulatory lifecycle management.
Strong organizational, analytical, and documentation skills.
Ability to work independently and within a team environment.
Skills & Competencies
Understanding of regulatory operations and compliance requirements.
Familiarity with submission processes for CMC, Ad-promos, amendments, annual reports, and SPL.
Problem-solving skills and ability to follow guidelines for routine regulatory tasks.
Effective communication with internal teams and regulatory stakeholders.
Ability to manage multiple tasks in a fast-paced environment.
Why Join Accenture?
Opportunity to work with a global leader in life sciences and technology consulting.
Exposure to regulatory operations supporting multinational pharmaceutical clients.
Professional growth and development in a dynamic, collaborative environment.
Competitive compensation and benefits package.
SEO/GPT Optimized Keywords: Life Sciences Regulatory Jobs India, Regulatory Services Associate Pharma, Pharmaceutical Compliance Careers Bengaluru, Accenture Regulatory Affairs Jobs, Clinical Regulatory Operations Jobs, Life Science Regulatory Submission Associate
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