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Regulatory Operations Specialist

Job Location: PA - Berwyn

Regional Description: Northeast

Job Number: 00627815


- Job description

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions – underpinned by the world’s largest delivery network – Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at


This role resides within Accenture's Applied Life Sciences Solutions group. This group helps clients make a meaningful impact on patients’ lives by combining new science with leading-edge technology. We’re working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered.  Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.

Job Description

The Regulatory Operations Specialist will be accountable for providing technical guidance across all aspects of regulatory operations in order to ensure generation of the highest quality regulatory submissions for the client.

Key Responsibilities:

  • Manage the daily tasks associated with publishing, assigning publishing tasks, resolving document issues, and daily communication with the client 
  • Perform presentations, both to the client as well as internally at Accenture
  • Demonstrate a high level of regulatory operations expertise in one or more global regions e.g., US, Europe, Japan, Canada, Australia, Emerging Markets, etc
  • Submission publishing in electronic and paper formats 
  • Control submission content, being accountable for the receipt and workflow completion of all submission components, resulting in a high quality final product Conduct issue resolution, communicating with the client and their functional areas to ensure that all issues are resolved in a compliant manner 
  • Perform submission QC, resulting in a high quality final product 
  • Responsible for delivery of contracted commitments within budget and cost forecasting 
  • Drive improved capacity management of team operational resources
  • Work with the Operations Manager to develop milestones and timelines, to relay these objectives to the team, and to ensure that the team is successful in obtaining these goals 
  • Ensure that the team follows, and strictly adheres to, internal standards including Standard Operating Procedures, Guidance Documents, and Policies throughout the duration of the project

Basic Qualifications:

  • Minimum 3 years' of industry experience 
  • Minimum 1 year of experience in Project Management

Preferred Skills:

  • Bachelor's Degree 
  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and or cosmetic products from a global, regional and local perspective 
  • Experience with publishing software and tools used throughout the Pharmaceutical industry 
  • Experience in coordination and publishing to Global Health Authorities in electronic or paper formats
  • Working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines 
  • International regulatory understanding and experience in handling business process excellence 
  • Ability to support a multidisciplinary project team across multiple geographic locations to build collaborative relationships 
  • Experience establishing excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust 
  • Exhibit confidence in one's regulatory abilities and develops long term trusting relationships with project team members and clients 
  • Promote the professional growth of self to achieve individual and organizational goals
  • Proven regulatory generalist with a knowledge of drug development and knowledge of non Europe and US markets
  • Ability to work independently and manage stand alone regulatory projects, as well as being an effective team worker by contributing ideas and solutions to peers ensuring all client deliverables are maintained 
  • Ability to manage numerous projects at once

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.

Accenture is a federal contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.

Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

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