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Regulatory Operations Manager

Job Location: PA - Philadelphia

Regional Description: Northeast

Job Number: 00567989

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- Job description

Join Accenture and help transform leading organizations and communities around the world. The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance. Choose Accenture, and make delivering innovative work part of your extraordinary career.

People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.

Pharmaceuticals Processes professionals enable the processes involved in creating a new drug/therapeutic agent, from initial to manufacturing/distribution to marketing/sales and all related processes.

Regulatory Operations Managers are subject matter experts in multiple areas of regulatory operations. As part of project teams, Operations Managers are the primary operational contact for clients on regulatory submission content and quality so that client input is reflected as appropriate in the submission, and the submission format meets regulatory authorities' stated requirements.  Acting as or working closely with the Account Manager, in conjunction with the Project Manager, they track and resolve all budget, time, resource, and contractual issues to ensure smooth project deployment and maintenance.  Additionally, the Operations Manager must be prepared to assist the department by helping to define and achieve department goals. In addition to their project management responsibilities, including monitoring and reporting on execution of deliverable through all program/project phases, Operations Managers also have direct supervisory responsibilities.

 
Reporting directly to the Regulatory Operations Associate Director, the Regulatory Operations Manager’s primary responsibilities will include the following:

 
  • Oversees all activities conducted on the assigned team.  Escalation point for all team members.
  • Responsible as the team leader for being a role model to the entire publishing team 
  • Perform submission Quality Control, 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. 
  • Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference calls. 
  • Provide project-specific training to internal staff as well as offer ongoing direction/guidance to all team members throughout the project duration. 
  • Develop milestones and timelines, relay these objectives to the team, and 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. Maintaining a strong working knowledge of SOPs, GCPs and Regulatory guidance applicable to project scope (including corrective action plans and identifying trends) 
  • Ensure that specific Project Specifications, if they exist, are strictly adhered to throughout the duration of the project. 
  • Act as the primary liaison between third-party vendors and Accenture to ensure all submission project expectations are met in a timely manner. 
  • Keep the project within budget by properly managing resources. 
  • Adhere to sound Account Management principles, accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costing and timelines for projects associated with the assigned portfolio of projects; and minimizing EACs.
  • Client relationship management, building relationships with clients and potential clients, leading to growth of assigned accounts
  • Assist/lead departmental committees and innovation initiatives in the definition and achievement of standards and processes (e.g., continuous improvement, automation).
  • Create and deliver presentations, internally and externally (to clients/industry)
  • Responsible for development and management of direct reports 
  • Conduct performance reviews of team 

Basic Qualifications

  • Minimum of a Bachelor’s degree 
  • Minimum of 6 years of experience in a Life Sciences industry
  • Minimum of 5 years of experience in pharmaceutical regulatory operations
  • Minimum of 2 years of experience with managing clients and projects
  • Minimum of 2 years of working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)

     

 

Preferred Skills

  • Knowledge in handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective
  • Proven regulatory generalist with a good knowledge of drug development
  • Excellent international regulatory understanding and experience in handling business process excellence
  • Experience with publishing software and tools used throughout the Pharmaceutical industry
  • Experience in coordination and publishing of regulatory submissions for Invesitigational or Marketing Applications to Global Health Authorities in electronic, and paper formats
  • Proven ability to establish reputation as a regulatory operations subject matter expert
  • Experienced Team Leader or People Manager, skilled in managing employees
 
Professional Skills:
  • Self-motivated individual with initiative and an ability to work in a fast paced, high volume environment
  • Ability to promote the professional growth of self and others to achieve individual and organizational goals. 
  • People oriented with a mindset for customer service
  • Ability to travel
  • Excellent communication (written and oral) and interpersonal skills
  • Excellent organizational, multi-tasking, time-management skills; effective at managing many competing projects and consistent ability to fulfill commitments
  • Proven abilities to lead and/or work with multidisciplinary project teams across multiple geographic locations to build collaborative relationships
  • Proven ability to establish excellent working relationships with clients, peers and team members through integrity
  • Proven abilities to anticipate and address stakeholder needs in problem solving and risk mitigation


 

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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