PwC Pharma Regulatory Compliance - Manager in Louisville, Kentucky
Industry/Sector: Pharma and Life Sciences
Time Type: Full time
Travel Requirements: Up to 40%
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We’re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance.
To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future.
Pursue opportunities to develop existing and new skills outside of comfort zone.
Act to resolve issues which prevent effective team working, even during times of change and uncertainty.
Coach others and encourage them to take ownership of their development.
Analyse complex ideas or proposals and build a range of meaningful recommendations.
Address sub-standard work or work that does not meet firm's/client's expectations.
Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients.
Manage a variety of viewpoints to build consensus and create positive outcomes for all parties.
Focus on building trusted relationships.
Uphold the firm's code of ethics and business conduct.
Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants.
Minimum Year(s) of Experience :
5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry.
Minimum Degree Required : Bachelor's degree
Advanced degree i.e. Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC).
- Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas
a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to
Coordinating/preparing regulatory submissions (e.g., implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies
Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process.
Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations
Investigating regulatory history of similar products to assess approval or registration implications
b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives
c. Assisting with preparation of routine reports and regulatory agency communications
d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems
e. Assisting with review of promotional/advertising or educational items
- Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (e.g., principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (i.e., GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.).
Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor.
Demonstrates proven abilities and success in identifying and addressing clients’ or managers’ needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents.
Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference.
For positions in Colorado, visit the following link for information related to Colorado's Equal Pay for Equal Work Act: https://pwc.to/coloradoadvisorymanager.