Manager, Life Sciences, Regulatory Affairs

Kpmg Providence , RI 02940

Posted 2 months ago

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

  • 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

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, 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.

At KPMG, any partner or employee must be fully vaccinated or test negative for COVID-19 in order to go to any KPMG office, client site or KPMG event. In some circumstances, individuals who are not fully vaccinated may also be required to have a reasonable accommodation to not be fully vaccinated for COVID-19.

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Associate Life Sciences Regulatory Affairs

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VIEW JOBS 5/18/2022 12:00:00 AM 2022-08-16T00:00 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 an Associate in Customer & Operations for our Consulting practice. Responsibilities: * Deliver consulting projects for Life Sciences clients focused on process improvements or technology implementations in the Regulatory Affairs function * Perform analysis on regulatory-related processes, data, business requirements, operating models, IT systems * Support projects related to process transformation, operational improvements, and organizational redesign * Assist projects related to system implementations and/or digital solutions * Drive progress against project milestones to help ensure timely delivery of project deliverables * Provide input for engagement decisions, including work plan, timeline and project management Qualifications: * Minimum of two 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 * Strong understanding of Regulatory Affairs related data and documents as well as experience with Regulatory Information Management (RIM) or Document Management systems preferred * Excellent foundational skills including strong analytical, written and verbal communication skills, MS Office expertise, impactful client presence, compelling facilitation and presentation skills * Ability to travel up to 80% of the time and applicants must be currently authorized to work in the United States without the need for Visa sponsorship now or in the future 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, 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. At KPMG, any partner or employee must be fully vaccinated or test negative for COVID-19 in order to go to any KPMG office, client site or KPMG event. In some circumstances, individuals who are not fully vaccinated may also be required to have a reasonable accommodation to not be fully vaccinated for COVID-19. Kpmg Providence RI

Manager, Life Sciences, Regulatory Affairs

Kpmg