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Regulatory Affairs Associate Manager
Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services—all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 674,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners, and communities. Visit us at www.accenture.com.
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Regulatory Affairs Associate Managers are assigned to one or multiple projects in one or more areas of regulatory affairs (e.g., CMC, Labeling, Submission Support, Medical Devices). These individuals work independently as subject matter experts (SMEs) with clients leveraging their regulatory expertise and project leadership skills to ensure on-time and highest quality deliverables. In the US, this role is accountable for acting as an US Agent on behalf of clients, as well as providing strategic regulatory guidance for client consulting projects/eCTD submissions.
- Act as primary project contact with client, including, but not limited to, face-to-face meetings, presentations, phone calls, email, and conference call interaction.
- Conduct regulatory reviews of technical summaries, quality, nonclinical and clinical study reports, and administrative documents for regulatory filings.
- Assist with the filings and approval processes for Investigational and Marketing product applications.
- Provide guidance with content placement within the Common Technical Document (CTD) and electronic CTD filings.
- Assist Sponsor/Client with identification of content required for Original applications and Life-cycle maintenance submissions.
- Author/review of specific Module 1 administrative documents such as, cover letters, submission forms, reviewer’s guides, meeting requests, and meeting materials.
- Provide mentoring and internal training support to Regulatory Affairs and Operations staff.
- Assure submissions adhere to appropriate Health Authority regulations guidelines.
- Assure submission process and standards adhere to Accenture SOPs.
- Interact with clients regarding regulatory issues.
- Interact with clinical, data management and technical staff as a member of a cross-functional project team.
- Liaise with Health Authorities on behalf of client as a Regulatory Affairs Representative, as assigned.
- Responsible for accurate tracking and reporting of project hours.
- Responsible for Managing Project Timelines.
- As needed, assist Department Managers in producing proposal and business development materials and documentation.
- Drive departmental/cross-functional initiatives (e.g., to develop/implement regulatory services, to improve current processes and procedures).
- Conduct performance reviews as applicable.
- 5 years of experience in pharmaceutical regulatory affairs including a working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines FDA, EMA, etc.
- 2 years of experience with managing projects
- Bachelor’s Degree
- Regulatory Affairs Certification (e.g., RAC) preferred.
- Knowledge and/or experience in the management of Investigational applications and marketing applications.
- Knowledge of Health Authority Regulations and Guidance in one or multiple regions (US, EU, Canada, other).
- Supervisory experience.
As required by the Colorado Equal Pay Transparency Act, Accenture provides a reasonable range of minimum compensation for roles that may be hired in Colorado. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For the state of Colorado only, the range of starting pay for this role is $62,640 – $143,899 and information on benefits offered is here.
Subject to applicable law, please be aware that Accenture requires all employees to be fully vaccinated as a condition of employment. Accenture will consider requests for accommodation to this vaccination requirement during the recruiting process.
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Requesting An Accommodation
Accenture is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Accenture and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
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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.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
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Job posted: 2022-04-24