Manager, Life Sciences, Regulatory Affairs Strategy Pharma

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 Regulatory Affairs Strategy Pharma in Customer & Operations for our Consulting practice.

Responsibilities:

• Deliver advisory services to Pharmaceutical and Life Sciences clients, primarily to the Regulatory Affairs function

• Advise clients throughout the product development pathway from early phase development and clinical trials to marketing authorization and maintaining compliance for approved products in global markets

• Support Regulatory Affairs services with an emphasis on regulatory strategy and activities that enable preparation, review and submission of documents to health authorities globally

• Provide consultation on regulatory requirements to support regulatory submissions to health authorities in different global jurisdictions

• Assist teams responsible for the technical review, authoring or assembly of Clinical, Pre-Clinical or CMC dossiers, for example preparation and maintenance of IND, CTA, NDA, BLA, MAAs or scientific advice procedures with global health authorities

• Engage with clients on the impact of the changing pharmaceutical regulatory landscape on their business models and support them through change

• Minimum five years of recent consulting or business experience or combination thereof in the Life Sciences industry coupled with professional services or consulting experience preferred

• Bachelor's degree from an accredited college/university; Master's degree from an accredited college/university and prior management consulting experience preferred

• Significant experience working in or consulting with Regulatory Affairs functions within Pharmaceutical and Life Sciences companies; strong experience interacting with major health authorities including FDA and EMA

• Understanding of pharmaceutical regulations and an ability to identify and interpret legislation, guidelines, and relevant information published by global health authorities; relevant certifications preferred such as Regulatory Affairs Certification (RAC); 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 as needed 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, 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).