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Lifescience Regulatory Svs Specialist

Accenture
Accenture
5-10 years
preferred by company
10 Jan. 16, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Life Sciences Regulatory Services Specialist

Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 5–10 years in Life Sciences Regulatory Operations
Job ID: AIOC-S01620287


About Accenture

Accenture is a global professional services leader, delivering unmatched expertise in digital, cloud, and security. With a workforce of over 699,000 people across more than 120 countries, Accenture combines strategy, consulting, technology, and operations to help clients transform their businesses. In Life Sciences, we empower leading biopharmaceutical companies to improve patient outcomes by aligning scientific expertise with insights into the patient journey.


Role Overview

The Life Sciences Regulatory Services Specialist will support regulatory operations across Accenture’s Life Sciences R&D vertical. This role focuses on enabling global biopharma companies to meet regulatory compliance, streamline submission processes, and ensure timely approvals. You will manage regulatory documentation, process electronic submissions, and collaborate with cross-functional teams to support research, clinical trials, pharmacovigilance, and patient services.

This position combines technical expertise with strategic insight to ensure regulatory submissions are accurate, complete, and aligned with global regulatory requirements.


Key Responsibilities

  • Prepare and manage regulatory submissions for global applications, including original filings, Life Cycle Management (LCM) submissions such as CMC updates, advertising/promotional materials, amendments, annual reports, and SPL submissions.

  • Conduct regulatory analysis to interpret applicable laws, guidelines, and standards, ensuring organizational compliance.

  • Coordinate documentation and resources required for timely and accurate submission to regulatory authorities.

  • Monitor changes in regulatory requirements and communicate updates to internal stakeholders.

  • Conduct compliance audits and identify gaps, recommending corrective actions as needed.

  • Collaborate with internal teams, clients, and external stakeholders to resolve moderately complex regulatory challenges.

  • Provide guidance to junior team members and may oversee small teams or work efforts.

  • Participate in process improvement initiatives to enhance efficiency in regulatory operations.

  • Adhere to organizational strategic directions and senior management objectives while executing daily responsibilities.

  • Work in rotational shifts as required to support global submission timelines.


Required Qualifications & Experience

  • Bachelor’s degree in Pharmacy or equivalent life sciences qualification.

  • 5–10 years of experience in regulatory affairs, regulatory operations, or life sciences submissions.

  • Proficient in electronic submission management, including CTD, eCTD, and regulatory life cycle management.

  • Strong knowledge of global regulatory guidelines, ICH regulations, and GxP compliance.

  • Excellent analytical, problem-solving, and project management skills.

  • Strong written and verbal communication skills, with the ability to interact with internal and external stakeholders.

Desirable:

  • Experience in clinical trial support, pharmacovigilance, or regulatory compliance audits.

  • Familiarity with global biopharmaceutical regulatory environments and submission platforms.


Why Join Accenture

  • Work at a global leader in digital and life sciences consulting, supporting transformative biopharma projects.

  • Collaborate with diverse teams across multiple countries and therapeutic areas.

  • Contribute directly to improving patient outcomes and regulatory compliance in leading biopharmaceutical companies.

  • Opportunity for professional growth, leadership development, and exposure to global regulatory practices.


Application Instructions:
Candidates meeting the required experience are invited to apply for the Life Sciences Regulatory Services Specialist position in Bengaluru. This is a full-time role offering opportunities to lead regulatory submissions, ensure compliance, and drive strategic life sciences operations.

Accenture is an equal opportunity employer and values diversity. Applications are welcomed from all qualified candidates, and we comply with all applicable employment regulations globally.