Lifescience Regulatory Svs Analyst

3-5 years

Not Disclosed

Hyderabad

10 Dec. 27, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm 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

Location: Multiple Locations
Company: Accenture

About Accenture:

Accenture is a global leader in professional services, offering capabilities in digital, cloud, and security. Combining unmatched experience with specialized skills across more than 40 industries, Accenture provides Strategy and Consulting, Technology and Operations services, and Accenture Song. Our 699,000 professionals deliver technology and human ingenuity every day, serving clients in more than 120 countries. We embrace change to create value and success for our clients, employees, partners, and communities.

For more information, visit www.accenture.com.

Role Overview:

As a LifeScience Regulatory Services Analyst, you will be part of Accenture’s Life Sciences R&D vertical, helping biopharma companies improve patient outcomes. You will handle regulatory operations tasks such as bookmarking and hyperlinking documents for submission, performing quality control checks, and transforming source documents to meet regulatory standards. You will also coordinate the necessary documentation for global application filings, life cycle management submissions, and other regulatory processes.

Key Responsibilities:

Regulatory Operations: Perform tasks like bookmarking and hyperlinking submission components according to ICH guidelines and other health authority requirements.
Document Quality Control: Conduct QC checks for all submission components to ensure accuracy and compliance.
Document Transformation: Review and transform source documents to meet the format required by regulatory authorities.
Global Submissions: Manage electronic submissions for original applications, amendments, and life cycle management submissions (CMC, ad-promos, annual reports, SPL, etc.).
Collaboration: Work with internal teams to gather essential documentation and resources for regulatory filings.
Issue Resolution: Address and resolve lower-complexity problems related to regulatory operations.

Qualifications:

Educational Background:
- Bachelor of Pharmacy or Master of Pharmacy.
Experience:
- 3 to 5 years of experience in regulatory operations or related fields.
Skills:
- Strong problem-solving and analytical skills.
- Excellent written and verbal communication skills.
- Ability to learn quickly and adapt to new systems and processes.
- Flexibility to handle multiple tasks and priorities under pressure.

What We Are Looking For:

Quick Learner: Ability to adapt to new regulatory processes and systems quickly.
Problem-Solving: Strong ability to analyze and address regulatory issues.
Communication: Ability to communicate effectively with peers and supervisors.
Adaptability: Ability to handle shifting priorities and work under pressure.
Teamwork: Ability to collaborate effectively in a team-oriented environment.

Why Accenture?

Career Growth: Opportunities to expand your career within the life sciences and regulatory sectors.
Collaborative Environment: Work with a global team of experts to help deliver regulatory services for biopharma companies.
Impact: Your work will play a crucial role in ensuring the timely submission of vital health-related documents and improving patient outcomes.

What We Offer:

Competitive Compensation: Salary based on experience.
Benefits: Health insurance, wellness programs, paid leave, and other employee benefits.
Career Development: Training and growth opportunities in a dynamic industry.

How to Apply:

If you’re ready to join a global leader in life sciences and regulatory operations, apply now at Accenture Careers.

Equal Opportunity Employer:

Accenture is an equal opportunity employer committed to diversity and inclusion. We embrace and value diverse perspectives to create a workplace where everyone can thrive.

Join Accenture and contribute to the global efforts in improving patient outcomes!

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Lifescience Regulatory Svs Analyst

Job Description

Job Title: LifeScience Regulatory Services Analyst

About Accenture:

Role Overview:

Key Responsibilities:

Qualifications:

What We Are Looking For:

Why Accenture?

What We Offer:

How to Apply:

Equal Opportunity Employer:

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