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Regulatory Operations Manager

Job Location: London

Regional Description: United Kingdom

Job Number: 00491503

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- Job description

Role: Regulatory Operations Manager
Location: London
Salary: £42,000 - £56,300
Travel: 10%
 
Introduction:
Join Accenture and help transform leading organisations 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. 
 
Join Accenture Operations and you will become part of the largest and most diverse group of business operations specialists in the world. You will be part of a team which provides business process excellence, implements leading cloud technology and builds and transforms client infrastructure services. 
 
We are constantly seeking new ways to achieve high performance in our clients’ business operations! We provide technology-enabled business process services to deliver business outcomes and are constantly seeking new ways to achieve high performance in our clients’ business operations.
 
Purpose of Role:
Regulatory Operations Managers are subject matter experts in multiple areas across regulatory operations and have a management role within Accenture. Responsible for Regulatory Operations delivery teams, RO Managers are the primary operational contact for global clients on regulatory submission content and quality to ensure that client input is reflected as appropriate in the submission, and the submission format meets regulatory authorities' stated requirements.  Working closely with the Account and/or Project Manager, they track and resolve all budget, time, resource, and contractual issues to ensure smooth project deployment and maintenance. 
 
RO Managers further offer regulatory operations consulting to clients. This includes development of regulatory operations strategic solutions, quality management, implementation, execution and continuous improvement.  
 
In addition to their global submission client project management responsibilities, including monitoring and reporting on execution of deliverables through all program/project phases, Regulatory Operations Managers also have direct supervisory responsibilities - the RO Manager is responsible for management of the EU Regulatory Operations Team (line, resource and workload management).
 
Regulatory Operations Managers are also responsible for supporting business development, for development of new regulatory initiatives and innovation, continuous improvement of Accenture’s RO department and ensuring the success of the Accenture Accelerated Research and Development business goals.
 
 
What responsibilities will you have?
  • Oversee all activities conducted by the EU Regulatory Operations Team and acts as an escalation point for all team members - responsible as the team leader for being a role model to the global publishing teams.
  • Regular communication with the client, including face-to-face meetings, presentations, telephone, email, and conference calls.
  • Perform submission QC, 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.
  • Provide internal training, mentoring and supervisory support to Regulatory Operations staff as well as project-specific training to internal staff and ongoing direction/guidance to all publishing team members throughout the project duration.
  • Develop milestones and timelines, relay these objectives to the team, and ensure that the team is successful in reaching 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, as well as project-specific specifications.
  • Act as the primary liaison between third-party vendors and Accenture to ensure all submission project expectations are met in a timely manner.
  • Manage resources, workload and budget for global publishing projects involving the EU RO Team
  • Manage relationships and coordinate work between different teams in different locations ensuring that internal and external project resources with appropriate skill sets are utilized.
  • Monitor and report on execution of regulatory operations activities – monitor and report on deliverables and resource and workload management through all program/project phases.
  • Assist/lead departmental committees and initiatives in the definition and continued development of standards and processes.
  • Maintain global intelligence of product/project related HA regulations, submission guidance, recent approvals and precedents for clients’ therapeutic area and/or assigned projects.
  • Provide specialist support of Business Development Activities as well as participate in meetings with potential clients in the proposal and delivery stages of customer engagement.
  • Monitor existing services and Accenture capabilities to identify opportunities which provide additional and innovative value to the client.
  • Create and deliver presentations, internally and externally (to clients/industry)
  • Provide strategic input into global regulatory operations plans for client, considering the full breadth of Accenture capability and taking into account Health Authority (HA) regulations and guidelines, and issues or topics directly related to the project.
  • Responsible for development and management of direct reports, and pro-active supervision.
What skills & experience are we looking for?
  • Ability to lead multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, health authorities and other experts in the Regulatory field.
  • Proven project management skills, ability to work on numerous simultaneous projects, and proactively fulfil commitments to the client and Accenture
  • Experience of or exposure to sales process and management of financials
  • Ability to anticipate and address stakeholder needs in problem solving and risk mitigation.
  • Ability to establish excellent long-term working relationships with clients, peers and team members through passion, integrity, credibility, reliability and trust.
  • Established reputation as a regulatory operations subject matter expert across strategic as well as delivery and technical aspects of Regulatory Operations..
  • Proven Regulatory generalist with a good knowledge of drug development and knowledge of non-EU/US markets
  • Outstanding communication (written and oral) and interpersonal skills as a key contact for clients and publishing team.
  • Promotes the professional/personal growth of self and others to achieve individual and organizational goals.
  • Self-motivated individual with initiative and an ability to work in a fast paced, high volume environment.  
  • Experienced Team Leader or People Manager, skilled in managing employees.
  • Attention to detail and quality orientation.
  • People-oriented with a mindset for both customer service and personal development
 
Functional Competencies:
  • Assembly of CTD and Ectd
  • Expert knowledge of eCTD including eCTD viewer.
  • In depth understanding of global regulations and submission requirements necessary for eCTD compilation, validation, submission and approval.
  • Expert in eCTD lifecycle maintenance, proactively providing best strategy for all types of regulatory submissions (including, not limited to annual reports, variations, and supplements)
  • Author regulatory documents.
  • Demonstrate proficiency in performing eCTD submission build (for example, leaf structure and backbone) or QC NeeS or paper submission output.
 
Technical Skills:
  • Answer regulatory questions from client. 
  • Use industry-standard publishing and familiarity with regulatory information management tools
  • Interpret and apply ICH, US and European guidance to projects.
  • Provide strategic regulatory operations guidance to clients.
  • Use regulatory knowledge to propose new initiatives.
  • Provide regulatory operations training both internally and externally (clients).
  • BD Activities: RFI, RFP, workshops and bid defences
  • Provide and defend Regulatory Operations solutions for Tier 1 clients
 
Customer Service and Communication
  • Excel at client management.
  • Conflict resolution with client.
  • Seen as a technical expert for answering regulatory questions for the client.
 
Business Development and Communication
  • Ensure seamless interaction of RO department with rest of Accelerated R&D and Accenture.
  • Focus firmly on the client, exhibiting front-line accountability and ownership to bring the best of Accenture to support client needs. Manage client expectations, ensure the client receives the benefit and value promised, and facilitate conflict and issue resolution, to enhance client relationships and service delivery.
 
Problem Solving Techniques
  • Provides solutions to complex business problems for area(s) of responsibility where analysis of situations requires an in depth technical and organizational knowledge.
  • Is an inspiration for innovation and drives efficiencies and continuous improvement.
 
Leadership Skills
  • Strong and positive team leadership
  • Resolve performance issues with delivery leadership
  • Implement levers to consistently achieve performance targets
  • Fosters innovation and continuous improvement
 
Interpersonal Interaction
  • Fosters team work through exceptional leadership skills.
  • Imparts vast technical and operational knowledge both internally and externally.
  • Work well under pressure.
  • Build credibility with HA, clients and colleagues
 
Interpersonal Interaction
  • Build credibility with Tier 1 clients as a RO expert
 
Negotiation and Influence
  • Interacts with management levels at a client and/or within Accenture, which involves negotiating or influencing on significant matters.
  • Point of escalation for client issues.
  • Help clients with best negotiation strategy/conflict resolution with HA regarding Regulatory Operations matters.
 
Attention to Detail
  • Demonstrate attention to detail.
 
Supervision
  • Supervise Regulatory Operations staff (level 9 and below).
 
Project Management
  • Excel at project management/leadership.
  • Manage a variety of regulatory projects and clients.
  • Lead regulatory delivery strategy across all geographic regions.
  • Drive optimization of regulatory solutions.
  • Support the achievement of targets on contract controllable income (CCI) and cost-to-serve.
  • Achieve year on year efficiencies for regulatory deliverables.
 
Team Management
  • Manage staffing assignments and role changes.
  • Support recruiting and interviewing potential new team members.
  • Balance workloads and skill sets across clients to support one-to-many delivery.
  • Manage and develop team, capitalizing on the resources available for professional and personal development within the entire Accenture organisation.
What academic qualifications do you need?
  • Bachelor’s degree in natural science, life sciences or pharmacy; advanced degree is preferred. Minimum 6 years’ experience in a Life Sciences industry with a minimum 5 years of experience in pharmaceutical regulatory operations
  • Minimum 2 years’ experience in Project Management
  • Broad domain knowledge - knowledge of handling registrations and maintenance of pharmaceutical, medical device, consumer and/or cosmetic products from a global, regional and local perspective.
  • 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 Investigational (IND, CTA) or Marketing Applications (e.g. NDA, MAA, NDS, MAA) to Global Health Authorities in eCTD, NeeS, or paper formats
  • A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.)
  • Ability to travel and deploy without extended notice.
 
What’s in it for you?
 
All of our Operations professionals receive comprehensive training covering business acumen, technical and professional skills development. You'll also have opportunities to hone your functional skills and expertise in an area of specialisation. We offer a variety of formal and informal training programs at every level to help you acquire and build specialised skills faster. Learning takes place both on the job and through formal training conducted online, in the classroom, or in collaboration with others. The sheer variety of work we do, and the experience it offers, provide an unbeatable platform from which to build a career.
 
On top of this, we have an extensive benefits package which includes 25 days’ vacation per year, gym subsidies, private medical insurance and 3 extra days leave per year for charitable work of your choice!
 
What are the next steps?
 
If this sounds like the ideal role, career and company for you, click below to apply.
 
About Accenture
 
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 specialised 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. Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.
 
Accenture is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, or gender identity or any other basis as protected by applicable law.
 
Closing Date for Applications: 31/08/2017
Accenture reserves the right to close the role prior to this date should a suitable applicant be found.
 

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