HIA Pharma & Life Sciences Regulatory Affairs - Senior Associate

Company: PwC
Location: Denver
Posted on: June 12, 2021

Job Description:

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 problems.
• 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 relevance.
• Share relevant thought leadership.
• Use straightforward communication, in a structured way, when influencing others.
• Able to read situations and modify behavior to build quality, diverse 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: 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).

Knowledge Preferred:

1. 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

2. 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 whitepaper, and attendance at industry conference.

Keywords: PwC, Denver , HIA Pharma & Life Sciences Regulatory Affairs - Senior Associate, Other , Denver, Colorado