LifeScience Regulatory Svs Analyst

Accenture; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

A leading consulting firm in India is seeking a LifeScience Regulatory Services Analyst to support regulatory compliance and documentation for global pharmaceutical applications. The ideal candidate will have a Bachelor of Pharmacy and 3 to 5 years of relevant experience. Responsibilities include preparing documentation, understanding regulatory requirements, and ensuring efficient compliance. Strong analytical and problem-solving skills are essential for success in this role, which may involve working in rotational shifts.

Qualifications

• 3 to 5 years of experience in a relevant field.
• Experience with regulatory submissions and compliance processes.

Responsibilities

• Provide guidance on regulatory requirements.
• Prepare necessary documentation for regulatory authorities.
• Coordinate documentation for global application filings.

Skills

Regulatory compliance

Document management

Analytical skills

Problem-solving

Education

Bachelor of Pharmacy

Job description

About The Role

Skill Required

Regulatory Services - Life Sciences Regulatory Operations

Designation

LifeScience Regulatory Svs Analyst

Qualifications

Bachelor of Pharmacy

Years of Experience

3 to 5 years

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.

Roles and Responsibilities

• Analysis and solving of lower‑complexity problems.
• Day‑to‑day interaction with peers within Accenture before updating supervisors.
• Limited exposure with clients and/or Accenture management.
• Receiving moderate level instruction on daily work tasks and detailed instructions on new assignments.
• Decisions made impact your own work and may impact the work of others.
• Work as an individual contributor as part of a team, with a focused scope of work.
• Position may require working in rotational shifts.

Qualification

Bachelor of Pharmacy