PwC Pharma Regulatory Affairs Compliance - Senior Manager in Birmingham, Alabama
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 Senior 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:
Encourage everyone to have a voice and invite opinion from all, including quieter members of the team.
Deal effectively with ambiguous and unstructured problems and situations.
Initiate open and candid coaching conversations at all levels.
Move easily between big picture thinking and managing relevant detail.
Anticipate stakeholder needs, and develop and discuss potential solutions, even before the stakeholder realises they are required.
Contribute technical knowledge in area of specialism.
Contribute to an environment where people and technology thrive together to accomplish more than they could apart.
Navigate the complexities of cross-border and/or diverse teams and engagements.
Initiate and lead open conversations with teams, clients and stakeholders to build trust.
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 : 7 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 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 whitepaper, 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/coloradoadvisoryseniormanager.