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.
As a Senior Associate, you'll work as part of a team of problem
solvers, helping to solve complex business issues from strategy to
execution. PwC Professional skills and responsibilities for this
management level include but are not limited to:
- Use feedback and reflection to develop self awareness, personal
strengths and address development areas.
- Delegate to others to provide stretch opportunities and coach
to help deliver results.
- Develop new ideas and propose innovative solutions to
- Use a broad range of tools and techniques to extract insights
from from current trends in business area.
- Review your work and that of others for quality, accuracy and
- Share relevant thought leadership.
- Use straightforward communication, in a structured way, when
- Able to read situations and modify behavior to build quality,
- 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: 3 years of Client Facing Advisory
Consulting experience is preferred, but open to PLS Risk &
Regulatory experience in Industry.
Minimum Degree Required: Bachelor's degree
Degree Preferred: 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
a. Ensuring adherence to pharmaceutical and medical device
product development, approval and registration
requirements/processes both US and globally including, but not
- 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
- 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
d. Assisting with building, updating and maintaining
paper/electronic regulatory document archival systems
e. Assisting with review of promotional/advertising or
- 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 whitepaper, and attendance at