Job Title:
LifeScience Regulatory Services Associate
Job ID:
AIOC-S01599241
Location:
Bengaluru, India
Employment Type:
Full-Time
Experience Required:
1 to 3 years
Qualifications:
Master of Pharmacy (M.Pharm)
About Accenture
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Business Function:
Life Sciences R&D Vertical
Sub-offering: Clinical, Pharmacovigilance & Regulatory
This team supports global biopharma companies in transforming how they bring products to market, centering solutions around patient needs.
Key Responsibilities:
Perform Regulatory Operations tasks including:
Bookmarking and hyperlinking of submission components (granular documents).
Reviewing and transforming source documents per ICH guidelines and Health Authority (HA) requirements.
Perform Quality Control (QC) checks on submission documents.
Coordinate documentation and resources needed for filing global regulatory applications.
Manage and process electronic submissions, including:
Original applications
Life Cycle Management (LCM) submissions (e.g., CMC, amendments, annual reports)
SPL submissions
Ad-promos
Required Skills:
Excellent written and verbal communication
Strong team collaboration
Results-oriented mindset
Quick learning capability
Effective problem-solving skills
Roles and Expectations:
Solve routine problems using established guidelines and precedents.
Interact primarily with your own team and direct supervisor.
Receive detailed instructions for daily tasks and moderate instruction for new assignments.
Decisions impact own scope of work only.
Individual contributor within a team setup.
Must be willing to work in rotational shifts if required.
Why Join Accenture?
Be part of a world-class regulatory services team.
Gain exposure to global health authority requirements.
Collaborate on innovative life sciences and regulatory transformation projects.
Work in a dynamic and supportive learning environment.
Discover More:
Accenture Careers
Hiring Process
Interview Tips
Employee Benefits
Equal Opportunity Employer
Accenture is an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to:
Race
Religion
Gender identity
Sexual orientation
Disability or veteran status
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