HIA Pharma and Life Science - Regulatory Affairs Manager
Posted on: July 24, 2020
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 a
purpose-led and values-driven leader at every level. 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 Manager, 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:
- Develop new skills outside of comfort zone.
- Act to resolve issues which prevent the team working
- Coach others, recognise their strengths, and encourage them to
take ownership of their personal development.
- Analyse complex ideas or proposals and build a range of
- Use multiple sources of information including broader
stakeholder views to develop solutions and recommendations.
- Address sub-standard work or work that does not meet
- Use data and insights to inform conclusions and support
- Develop a point of view on key global trends, and how they
- Manage a variety of viewpoints to build consensus and create
positive outcomes for all parties.
- Simplify complex messages, highlighting and summarising key
- 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
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
degreeDegree Preferred: Advanced degree i.e. Juris Doctor, Masters
of Business Administration, Masters of Public Health, Masters in
Regulatory Affairs, RAPS Certification (RAC).Knowledge Preferred:1.
Demonstrates proven thorough knowledge of, and success performing
on, regulatory projects in more than one of the following areasa.
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
- Investigating regulatory history of similar products to assess
approval or registration implicationsb. Working in partnership with
the local teams to identify key regulatory requirements for
projects and business initiativesc. Assisting with preparation of
routine reports and regulatory agency communicationsd. Assisting
with building, updating and maintaining paper/electronic regulatory
document archival systemse. Assisting with review of
promotional/advertising or educational items2. 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.).Skills Preferred: 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.
All qualified applicants will receive consideration for employment
at PwC without regard to race; creed; color; religion; national
origin; sex; age; disability; sexual orientation; gender identity
or expression; genetic predisposition or carrier status; veteran,
marital, or citizenship status; or any other status protected by
law. PwC is proud to be an affirmative action and equal opportunity
For positions based in San Francisco, consideration of qualified
candidates with arrest and conviction records will be in a manner
consistent with the San Francisco Fair Chance Ordinance.
Keywords: PwC, Danbury , HIA Pharma and Life Science - Regulatory Affairs Manager, Executive , Danbury, Connecticut
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