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 responsibilities:

• 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.

• 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.
• Bachelor’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