Regulatory Operations Sr Coordinator

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Job Description

The Regulatory Operations Sr Project Coordinator 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.
  • Delivery of 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

Basic Qualifications
  • Bachelor's Degree
  • Minimum 3 years' of Pharmaceutical/Life Science industry experience
  • Minimum 1 year experience in Project Management

Preferred Skills
  • 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
  • A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by International Conference of Harmonization and Global Health Authority Guidelines
  • International regulatory understanding
  • Experience in handling business process excellence

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 (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

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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