Manager, Life Sciences, Regulatory Affairs

The KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we don't anticipate that slowing down. In this ever-changing market environment, our professionals must be adaptable and thrive in a collaborative, team-driven culture. At KPMG, our people are our number one priority. With a wealth of learning and career development opportunities, a world-class training facility and leading market tools, we make sure our people continue to grow both professionally and personally. If you're looking for a firm with a strong team connection where you can be your whole self, have an impact, advance your skills, deepen your experiences, and have the flexibility and access to constantly find new areas of inspiration and expand your capabilities, then consider a career in Advisory.

KPMG is currently seeking a Manager in Customer & Operations for our Consulting practice.

Responsibilities:

• Lead consulting projects for Life Sciences clients focused on process improvements or technology implementations in the Regulatory Affairs function
• Provide oversight of client and KPMG work teams throughout the project lifecycle and help ensure timely execution of project deliverables
• Facilitate engagement decisions, including work plan and timeline, project management, resource allocation, and career development of team members
• Structure and perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems
• Manage projects related to process transformation, operational improvements, and organizational redesign
• Oversee projects related to system implementations and/or digital solutions

Qualifications:

• Minimum of five years of work experience related to the Regulatory Affairs function within the pharmaceutical and/or medical device industry
• Bachelor's degree in an appropriate field from an accredited college/university; Master's degree from an accredited college/university preferred
• Experience with operational process improvement initiatives in pharmaceutical and/or medical device industry
• Prior professional services or consulting experience preferred along with a strong understanding of Regulatory Affairs related data and documents
• Experience with Regulatory Information Management (RIM) or Document Management systems preferred as well as experience serving on an implementation team for a RIM or Document Management system preferred
• Applicants must be currently authorized to work in the United States without the need for sponsorship now or in the future and the ability to travel as necessary

KPMG LLP (the U.S. member firm of KPMG International) offers a comprehensive compensation and benefits package. KPMG is an affirmative action-equal opportunity employer. KPMG complies with all applicable federal, state and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. The attached link contains further information regarding the firm's compliance with federal, state and local recruitment and hiring laws. No phone calls or agencies please.

KPMG does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to KPMG offices, client sites or KPMG events, except when mandated by federal, state or local law.  In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site).       /