PwC Biotech/Pharma Regulatory Affairs Compliance - Manager in Irvine, California
Specialty/Competency: Conduct and Compliance
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 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 effectively.
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 meaningful recommendations.
Use multiple sources of information including broader stakeholder views to develop solutions and recommendations.
Address sub-standard work or work that does not meet firm's/client's expectations.
Use data and insights to inform conclusions and support decision-making.
Develop a point of view on key global trends, and how they impact clients.
Manage a variety of viewpoints to build consensus and create positive outcomes for all parties.
Simplify complex messages, highlighting and summarising key points.
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.
At PwC, our work model includes three ways of working: virtual, in-person, and flex (a hybrid of in-person and virtual). Visit the following link to learn more: https://pwc.to/ways-we-work.
PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
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 employer.
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.
For positions in Colorado, visit the following link for information related to Colorado's Equal Pay for Equal Work Act: https://pwc.to/coloradoadvisorymanager.