Life Sciences Regulatory Operations Analyst - Regulatory Services

Why This Role Matters
Regulatory compliance is a fundamental aspect of the pharmaceutical and life sciences industry. Before medicines and healthcare products reach patients, they must undergo strict regulatory review processes to ensure safety, quality, and effectiveness. Regulatory professionals play a crucial role in preparing, managing, and submitting documentation required by global health authorities. As a Life Sciences Regulatory Services Analyst at Accenture, you will support regulatory operations that enable pharmaceutical companies to successfully navigate complex regulatory frameworks. Your work will involve coordinating regulatory documentation and supporting electronic submissions for global regulatory applications. By ensuring accurate preparation and timely submission of regulatory files, you help pharmaceutical companies maintain compliance with regulatory agencies and facilitate faster approvals for life-saving therapies. This role offers the opportunity to work at the intersection of science, documentation management, and global regulatory strategy while contributing to the development and approval of healthcare products.

Job Description
The Life Sciences Regulatory Services Analyst will work within Accenture’s Life Sciences Research and Development vertical, specifically under the Clinical, Pharmacovigilance & Regulatory sub-offering. This role focuses on regulatory operations and electronic submission management for global pharmaceutical clients. Employees in this role will support the preparation, organization, and submission of regulatory documentation required for product registrations and lifecycle management activities. The position involves coordinating documentation required for global applications and ensuring that electronic submissions are prepared and processed in compliance with regulatory authority guidelines.
Responsibilities include managing electronic submissions such as original product applications, lifecycle management submissions, chemistry manufacturing and control updates, advertising and promotional submissions, amendments, annual reports, and structured product labeling submissions. Employees will work closely with internal teams to gather required documentation and ensure accurate submission packages. The role also involves reviewing regulatory documentation for completeness and quality, maintaining submission records, and ensuring that all regulatory activities comply with global standards and internal operating procedures. The position requires strong attention to detail, the ability to work with structured regulatory processes, and effective collaboration with team members to meet project timelines. This is an individual contributor role where employees will analyze tasks, resolve lower-complexity issues, and work closely with peers and supervisors to support regulatory operations for pharmaceutical clients.

Key Features of the Role: Responsibilities
• Coordinate documentation and resources required for global regulatory application filings.
• Prepare and manage electronic regulatory submissions in accordance with regulatory authority requirements.
• Support lifecycle management activities including amendments, variations, and annual reports.
• Manage documentation related to chemistry manufacturing and control submissions.
• Assist in preparing advertising and promotional regulatory submissions when required.
• Support structured product labeling submission processes.
• Ensure that all regulatory submission packages are complete, accurate, and compliant with guidelines.
• Maintain regulatory documentation records and track submission timelines.
• Work with internal teams to gather required documents and resolve submission queries.
• Follow regulatory processes and standard operating procedures while maintaining high quality standards.

Required Qualifications
• Bachelor of Pharmacy from a recognized university or institution.
• 3 to 5 years of experience in regulatory affairs, regulatory operations, or pharmaceutical documentation management.
• Understanding of global regulatory submission processes and compliance requirements.
• Strong attention to detail and commitment to quality in regulatory documentation handling.
• Ability to work collaboratively in a team environment.
• Adaptability and flexibility to handle evolving regulatory processes and requirements.

Educational Requirements
• Bachelor’s degree in Pharmacy or a related life sciences discipline.
• Knowledge of regulatory submission standards and pharmaceutical documentation practices is beneficial.
• Familiarity with electronic regulatory submission systems and regulatory authority guidelines is preferred.

Experience and Skills
• 3 to 5 years of professional experience in regulatory operations or regulatory affairs within the pharmaceutical or life sciences industry.
• Understanding of electronic regulatory submissions and lifecycle management processes.
• Experience supporting global regulatory filing activities is advantageous.
• Strong analytical and problem-solving skills for resolving documentation and submission issues.
• Good communication and collaboration skills for working with cross-functional teams.
• Ability to follow structured processes and maintain high standards of regulatory compliance.

Salary Insights
• Competitive salary aligned with industry standards and candidate experience.
• Additional benefits may include health coverage, performance incentives, and professional development opportunities.

Company Overview
Accenture is a global professional services company known for its expertise in digital transformation, cloud technology, and business operations. With more than 784,000 employees serving clients in over 120 countries, Accenture helps organizations improve efficiency and drive innovation through technology and human expertise. Within the Life Sciences R&D vertical, Accenture provides services across clinical trials, pharmacovigilance, regulatory affairs, and patient services. These solutions help pharmaceutical and biotechnology companies accelerate research, ensure compliance with global regulatory authorities, and deliver safe and effective treatments to patients worldwide. Accenture fosters a collaborative work environment where employees can build expertise while contributing to advancements in global healthcare.

FAQs
• What is the main responsibility of this role?
The role focuses on managing regulatory documentation and supporting electronic submissions for global regulatory applications.

• Will this role involve working with regulatory authorities?
The role primarily supports submission preparation and coordination, while regulatory authorities receive the submissions prepared by the team.

• Is prior regulatory experience necessary?
Yes, candidates are expected to have 3 to 5 years of experience in regulatory operations or regulatory affairs.

Application Tips
• Highlight experience related to regulatory submissions, lifecycle management, and pharmaceutical documentation.
• Mention knowledge of electronic submission systems and regulatory guidelines if applicable.
• Emphasize your attention to detail, teamwork, and quality-focused work approach.
• Tailor your resume to demonstrate experience in regulatory compliance and global submission processes.