LifeScience Regulatory Services Associate
Company: Accenture
Department: Regulatory Services – Life Sciences Regulatory Affairs
Qualifications: Bachelor of Pharmacy
Experience: 1 to 3 years
Location: Not specified
About Accenture:
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries.
Role Overview:
You will be aligned with our Life Sciences R&D vertical, supporting clinical trials, regulatory services, pharmacovigilance, and patient services solutions. As a LifeScience Regulatory Services Associate, you will perform regulatory operations tasks such as bookmarking and hyperlinking submission documents according to ICH guidelines and other Health Authorities. Additionally, you will conduct Quality Control checks, collect and evaluate scientific data, and ensure compliance with current regulations.
Key Responsibilities:
| Responsibilities |
|---|
| Perform regulatory operations tasks (bookmarking, hyperlinking) |
| Review and transform Source Documents |
| Conduct Quality Control checks on submission components |
| Collect, collate, and evaluate scientific data |
| Advise on legal and scientific requirements |
| Ensure compliance with current regulations |
| Develop regulatory submission strategies |
| Author CMC documents and health authority packages |
Desired Skills:
- Adaptable and flexible
- Ability to perform under pressure
- Problem-solving skills
- Results-oriented
- Teamwork abilities
Additional Information:
- Individual contributor role
- Predetermined, focused scope of work
- Potential requirement for rotational shifts
Join Accenture and help the world’s leading biopharma companies bring their vision to life by improving patient outcomes through scientific expertise and unique patient insights.
Apply now at Accenture Careers to be a part of our team!