Job Description

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 specialized 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. With more than 482,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

 

Accenture Operations  provides business process services for specific functions, including finance and accounting; procurement and supply chain; and marketing & sales. We operate business processes with a combination of talent and data, artificial intelligence, analytics and digital technologies, helping clients to improve their productivity, customer experience and performance.

 

Regulatory Services Manager is subject matter experts across multiple areas of regulatory and have a management role within Accenture. The Regulatory Services Manager is responsible for: developing and executing complex end-to-end regulatory projects for the client; coordinating and prioritizing operational resources to ensure that resource allocation is appropriately managed with a global focus; growing client relationships; development of regulatory solutions, risk assessment and management, implementation, execution and continuous improvement, development of new regulatory initiatives, continuous improvement of Accenture’s Regulatory department and ensuring the success of Accenture Applied Life Sciences Solutions (AALSS) business goals.  Responsible for profit and loss of the contracts and owning the client relationship for the regulatory project. The Regulatory Services Manager will also support and manage the local resources in the geography for the Regulatory function including RA and RO personnel.

 

Key resposibilities:

  • Responsible for end-to-end project delivery, by defining and managing the overall project from scoping and requirements through deployment, ensuring timely delivery of high-quality project deliverables through effective team communications with a focus on quality.
  • Provide leadership and line management for 5-10 direct reports at different levels. Ensure the principles of performance management are used to develop staff to their full potential.

  • Client relationship management, building relationships with clients and potential clients, leading to growth of assigned accounts.

  • Support client relationship development, account planning and growth, including identification of new opportunities, tailoring business development activities to the specific client environment and achieving target revenue and profitability for their portfolios, including implementing recovery plans (if required).

  • Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs

  • Ensure the project stakeholders' expectations are understood, managed and that the overall project status is reported back to project sponsor and stakeholders.

  • Proactively takes steps to mitigate project risk as defined/required in project plan and ensures stakeholders clearly understand what risks will or will not be mitigated.

  • Manage relationships and coordinate work between different teams at different locations ensuring that internal and external project resources with appropriate skill sets are utilized.

  • Provide strategic input into global regulatory plans for client taking into account commercial strategy, Health Authority (HA) regulations and guidelines, and issues or topics directly related to the project.

  • Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.

  • Develop and implement service level agreements and other financial/operational metrics with clients.

  • Maintain established regulatory reputation through work with clients, HA and trade associations.

  • Assure standards adhere to Accenture and/or client SOPs and guidance.

  • Collaborate closely with Regulatory teams across Strategy, Consulting and Technology. Work Seamlessly with regulatory colleagues across the world.

  • Collaborate closely with local country level and regional Operations leadership.



Qualifications

  • Ability to lead a multidisciplinary project team across multiple geographic locations to build collaborative relationships with client, Health Authority and other experts in the regulatory field.
  • Establishes excellent working relationships with clients, peers and team members through integrity, credibility, reliability and trust.
  • Uses effective communication for one-on-one or small group conversations.
  • Promotes the professional growth of self and others to achieve individual and organizational goals.
  • Expertise in preparing and submitting all forms of regulatory documents.
  • Master’s degree in natural science, life sciences or pharmacy; advanced degree is preferred.
  • Minimum 7 years of experience in pharmaceutical regulatory affairs, or equivalent industry experience.
  • Knowledge in handling registrations and maintenance of pharmaceuticals and/or biologics from a global & regional perspective and excellent international regulatory understanding.

What we can offer

  • Using foreign language and new technology solutions daily, cooperating with various global Clients.
  • Constant support and clear development path from your first day at office – dedicated Buddy, who will help you in adjusting to the new workplace.
  • Focus on your strengths and continuous feedback enable fast professional growth, as well as new skills building by various online and classroom trainings.
  • Inclusion and diversity in practice: truly multicultural environment; we support LGBT, people with disabilities and parents. In our culture of equality, people are truly valued for their differences and free to be who they are.
  • A flexible approach that allows an appropriate work-life balance where sports activities, outings, volunteering initiatives are part of our regular day-to day life.
  • Commitment to reducing our environmental impact in terms of carbon, water and waste across Accenture facilities and in the communities in which we work and live by joining different initiatives.
  • Full work comfort – private medical care, life insurance, access to MyBenefit platform, bonuses for referring new employees.
  • Modern, ecological office in city center with convenient connection for all means of transport (incl. chill room, game room, free bicycle parking and coffee-breaks at terrace).

 

When applying please enclose the below statement: 
 
"I hereby consent to the processing of my personal data by Accenture sp. z o.o. with its registered seat in Warsaw (00-121), at ul. Sienna 39, NIP 526-00-15-900 (Data Controller), in accordance with the Act of August 29, 1997 on the Protection of Personal Data (Journal of Laws of 2016, item 922) and the Regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (Data Protection Directive), necessary to carry out the recruitment process by Accenture . At the same time, I declare that I provide my personal data completely voluntary. I also declare that I have been informed about my right to withdraw my consent or object to processing of data, request access to them, rectification, deletion, limitation of processing and their transfer, at any time and the right to lodge a complaint to the data protection supervisory authority."
 
Check out all our job vacancies at our website: www.accenture.pl/operationswarszawa    
 
Accenture does not discriminate employment candidates on the basis of race, religion, color, sex, age, disability, national origin, political beliefs, trade union membership, ethnicity, denomination, sexual orientation or any other basis impermissible under Polish law. 

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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