Director Life Sciences Regulatory Affairs

KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we do not 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 Director Life Sciences Regulatory Affairs EU MDR in Customer & Operations for our Consulting practice.

Responsibilities:

• Lead consulting projects for Life Sciences clients focused on process improvements or technology/data related implementations in Regulatory Affairs, Labeling and adjacent functions
• Run fast-paced client engagements for on-time and quality delivery of work products; be responsible for overall engagement planning, budgeting, staffing, financial management, deliverables and management of engagement team members
• Structure and perform analysis on regulatory related process, data, business requirements, operating models, IT systems etc
• Lead client engagements in optimizing Regulatory Affairs and adjacent functions by leveraging emerging technologies including Data Analytics, AI/ML and GenAI among others
• Provide domain expertise in regulated data models specific to Pharmaceutical and Medical Device companies as required by various regulatory agencies including but not limited to US FDA, EU, UK MHRA, TGA, Health Canada, India, China
• Assist life sciences companies in designing and implementing various regulated data requirements including but not limited to IDMP, UDI and EUDAMED
• Lead and support go-to-market efforts, new business development and on-going revenue management including representing KPMG thought leadership at conferences, in publications and other growth
  
  

Additional Responsibilities:

• Serve as a Performance Management Leader (PML) for the staff and mentor team members for their career growth, actively participate in staff recruitment and retention activities
  
  

Qualifications:

• Minimum ten years of Regulatory experience in consulting and/or industry roles in the Regulatory Affairs or Labeling domain within the Life Science industry (Pharmaceutical, Medical Device, BioTech and Clinical Research Organization) with prior professional services or consulting preferred
• Bachelors degree from an accredited college/university, preferably in Biology, Chemistry, Pharmacy, Biochemistry, Biomedical Engineering, or related field; graduate degree in a Healthcare or Life Sciences discipline such as MA, MSc, MPH, PhD or MD, or a Masters degree in Business or Healthcare Administration from an accredited college/university is highly preferred
• Experienced with common industry software solutions in the Regulatory and Labeling domains (e.g., Veeva, Rimsys, Loftware, Esko, etc.)
• Experience in regulatory pathways for pharmaceutical and/or medical device product approvals and changes across multiple regulatory jurisdictions globally with UDI and EUDAMED regulations preferred
• Experience implementing Regulatory Information Management (RIM), Labeling and/or Document Management systems
• Ability to travel as necessary
• Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future
  
  

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Follow this link to obtain salary ranges by city outside of CA:

https://kpmg.com/us/en/how-we-work/pay-transparency.html/?id=M128_2_24

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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).

KPMG recruits on a rolling basis. Candidates are considered as they apply, until the opportunity is filled. Candidates are encouraged to apply expeditiously to any role(s) for which they are qualified that is also of interest to them.

Los Angeles County applicants: Material job duties for this position are listed above. Criminal history may have a direct, adverse, and negative relationship with some of the material job duties of this position. These include the duties and responsibilities listed above, as well as the abilities to adhere to company policies, exercise sound judgment, effectively manage stress and work safely and respectfully with others, exhibit trustworthiness, and safeguard business operations and company reputation. Pursuant to the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.