Instagram
youtube
Facebook

Lifescience Regulatory Svs Analyst

3-5 years
Not Disclosed
10 Jan. 22, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: LifeScience Regulatory Services Analyst

Designation: LifeScience Regulatory Services Analyst
Skill Required: Regulatory Services - Life Sciences Regulatory Affairs
Qualification: Master of Pharmacy
Years of Experience: 3 to 5 years
Language Proficiency: English (Expert)


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. With 699,000 employees across more than 120 countries, we are committed to creating value and shared success for clients, people, shareholders, partners, and communities. For more information, visit www.accenture.com.


Role Overview:

As a LifeScience Regulatory Services Analyst, you will be aligned with the Life Sciences R&D vertical, providing critical regulatory affairs support across various life sciences functions. You will help leading biopharma companies navigate regulatory processes, improve patient outcomes, and connect scientific expertise with insights into the patient experience.

In this role, you will focus on building regulatory dossiers in compliance with ICH guidelines and other health authority requirements, transforming source documents, performing quality control (QC) checks for submission components, and ensuring products comply with current regulations.


Responsibilities:

  • Regulatory Affairs Support:

    • Build regulatory submission strategies and author CMC documents and health authority packages.
    • Transform source documents and perform quality control checks for all submission components.
    • Advise on legal and scientific restraints and regulatory requirements.
  • Scientific Data Collection and Evaluation:

    • Collect, collate, and evaluate scientific data gathered as part of R&D.
    • Ensure compliance of the organization’s products with current regulations.
  • Collaboration & Communication:

    • Interact primarily with peers within Accenture, providing updates to supervisors on work progress.
    • Limited exposure to clients and/or Accenture management.
  • Problem Solving:

    • Analyze and solve lower-complexity problems, with a focus on detail orientation and quick learning.
  • Documentation & QC:

    • Perform detailed quality control checks and ensure accuracy in regulatory documentation and submissions.
  • Shift Requirements:

    • This role may require you to work in rotational shifts based on business needs.

Skills & Qualifications:

Essential:

  • Master of Pharmacy (M.Pharm) or equivalent.
  • 3-5 years of experience in Life Sciences Regulatory Affairs.
  • Ability to adapt, learn quickly, and solve problems in a regulatory context.
  • Strong attention to detail and ability to work under pressure.
  • Proficient in the English language with strong written and verbal communication skills.

Desirable:

  • Knowledge of ICH guidelines and other Health Authority requirements.
  • Experience in building regulatory dossiers and working with regulatory submissions.

What Are We Looking For?

We are looking for a candidate who is adaptable, flexible, and able to perform effectively under pressure. You should have strong problem-solving abilities, attention to detail, and an agility for quick learning. Additionally, the candidate must possess excellent communication skills, both written and verbal, and the ability to work collaboratively in a team.


Why Accenture?

At Accenture, you will be part of a diverse and dynamic team that shapes the future of the life sciences industry. This is an exciting opportunity to contribute to regulatory services while working in a global professional services environment.


Equal Opportunity Statement:

Accenture is an equal opportunity employer and values diversity in its workforce. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.


Ready to make a difference? Apply today and join Accenture’s LifeScience Regulatory Services team!