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PwC PLS Regulatory Senior 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 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.

The Pharmaceutical Regulatory Affairs Senior Manager will use their experience and knowledge in pharmaceutical industry regulatory affairs to lead and manage complex projects for our clients in the pharmaceutical sector, and provide strategic advice, guidance, and solutions on regulatory matters. The senior manager will also contribute to business development, client relationship management, and team leadership.

Job Requirements and Preferences :

Basic Qualifications :

Minimum Degree Required :

Bachelor Degree

Minimum Years of Experience :

7 year(s)

Preferred Qualifications :

Degree Preferred :

Master Degree

Preferred Knowledge/Skills :

Demonstrates intimate-level experience in pharmaceutical industry regulatory affairs, with a track record of delivering successful outcomes for clients in complex and dynamic environments, including:

  • Knowledge of current and emerging regulations and guidelines in the US, EU, and other key markets;

  • Ability to provide strategic advice, guidance, and solutions to clients on regulatory issues, submissions, approvals, compliance, and audits;

  • Proven communication and interpersonal skills, with the capability to build rapport and trust with clients, stakeholders, and regulators;

  • A passion for innovation and continuous learning, with a keen interest in the latest trends and developments in the pharmaceutical industry;

  • An understanding of the regulatory landscape and processes for pharmaceutical products in the US and globally;

  • A proven track record of delivering high-quality regulatory outcomes and solutions for clients;

  • Project management, problem-solving, and analytical skills;

  • A demonstrated ability to lead and develop teams and foster a collaborative and inclusive culture;

  • A willingness to travel as required by client engagements;

  • Ability to delivery on day-to-day responsibilities, such as managing and delivering regulatory affairs projects for pharmaceutical clients, including regulatory strategy, submissions, compliance, and post-marketing activities, advising clients on current and emerging regulatory requirements and trends in the pharmaceutical industry, and developing and maintaining trusted relationships with clients, regulators, and other stakeholders;

  • Identify and pursue new business opportunities and expand PwC's presence in the pharmaceutical market;

  • Lead, coach, and mentor a team of regulatory affairs professionals; and,

  • Support PwC's thought leadership and innovation initiatives in the pharmaceutical sector.

Learn more about how we work: https://pwc.to/how-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 California, Colorado, Hawaii, Nevada, New York State, or Washington State, or for opportunities that will report to a supervisor, office or other work site in New York State, please visit the following link for pay range information: https://pwc.to/payrange-v1-advisoryseniormanager