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
- 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.
- 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.
- Strong and positive team leadership
- Resolve performance issues with delivery leadership
- Implement levers to consistently achieve performance targets
- Fosters innovation and continuous improvement
- 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
- 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.
- Supervise Regulatory Operations staff (level 9 and below).
- 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.
- 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.
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.