Senior Regulatory Services Associate

Accenture in India; Bengaluru; On-site; INR 500,000 - 750,000; Full time

Job summary

Accenture in Bengaluru is seeking a Senior Regulatory Services Associate to support life sciences regulatory operations. The role involves assisting with regulatory submissions, maintaining documentation, and coordinating with cross-functional teams. Bachelor of Pharmacy is required and 3–5 years of experience is expected.

Rotation shifts may be involved depending on operations. You will be aligned with our Life Sciences Regulatory Operations, contributing to ensure compliance and timely filings

Qualifications

• Ability to build client relationships and manage multiple stakeholders.
• Ability to meet deadlines and work under pressure.
• Experience with regulatory services and lifecycle submissions.

Responsibilities

• Perform analysis and solving of lower-complexity regulatory problems.
• Interact with peers and Accenture management for daily tasks and updates.
• Support documentation and filing activities for global regulatory submissions.

Skills

Client relationship

Stakeholder management

Deadline oriented

Regulatory operations

Education

Bachelor of Pharmacy

Job description

Skill required: Regulatory Services - Life Sciences Regulatory Operations

Designation: Senior Regulatory Services Associate

Qualifications: Bachelor of Pharmacy

Years of Experience: 3- 5 Yrs

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- all powered by the world's largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities. Visit us at www.accenture.com

What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Regulatory Services involves helping organizations comply with laws and regulations. This role includes providing guidance on regulatory requirements, preparing necessary documentation, and submitting reports to regulatory authorities. It also involves staying updated on regulatory changes and conducting compliance audits. The goal is to ensure the organization meets all legal and regulatory obligations efficiently. Coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

What are we looking for?

• Ability to establish strong client relationship
• Ability to handle disputes
• Ability to manage multiple stakeholders
• Ability to meet deadlines
• Ability to perform under pressure Roles and Responsibilities:
• In this role you are required to do analysis and solving of lower-complexity problems
• Your day to day interaction is with peers within Accenture before updating supervisors
• In this role you may have limited exposure with clients and/or Accenture management
• You will be given moderate level instruction on daily work tasks and detailed instructions on new assignments
• The decisions you make impact your own work and may impact the work of others
• You will be an individual contributor as a part of a team, with a focused scope of work
• Please note that this role may require you to work in rotational shifts