Regulatory Manager
Z's Associates, Inc

Princeton, New Jersey

Posted in IT


This job has expired.

Job Info


ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people-a fact that's reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond.

ZS Associates' Business Consulting group delivers solutions to a broad spectrum of Life Sciences challenges. We also help our clients transform their organizations to implement these solutions. Our solutions and recommendations are based in rigorous research and analysis underpinned by deep expertise and thought leadership.

ZS' R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology, to empower client organizations achieve their passion for patient care, science and business success. Through our "Clinical Development Excellence", "Medical Affairs" and "Real World Evidence", "Regulatory", "Bio-Medical Research" and "Health Economics and Outcome Research (HEOR)" services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area and will be responsible for leading and enhancing our service in Regulatory.

The Role: Regulatory SME will have the responsibility of driving the development and growth of the regulatory book of business working with the Practice Leader. As an SME, you will:

  • Lead delivery of regulatory (& safety) advisory & technology initiatives and provide SME support.
  • Support the development of long-term strategy for regulatory (& Safety) services. Help create and execute annual growth plans
  • Lead business development for regulatory book of business at one or key large Pharma clients
  • Help ZS in market assessment of opportunities to penetrate in regulatory (and Safety) services space pertaining to use of data sciences and modern technologies
  • Identify talent needs and build the team via external and internal hiring and training
  • Provide thought leadership and lead industry outreach as a market leader
  • Identify industry gaps and help create consulting and technology solutions. Lead Productization and commercialization of regulatory assets
  • Be a trusted advisor to clients. Establish and maintain executive level relationships with regulatory client leadership, decision makers and regulatory technology leadership
  • Coach, mentor and evaluate the Regulatory team
  • Work cross functionally across ZS teams to partner for overall client delivery
Qualifications:
  • MBA with bachelor's degrees with a strong academic record in business, medical or life sciences, engineering, applied math, statistics or related fields. Alternately, candidates may possess a Masters (preferably PhD or MD) in pharmaceutical sciences, decision sciences or related field with a business application.
  • 10+ years of experience, with at least a minimum of 8 years of global experience, in the life science industry in regulatory strategy or planning functions
  • 5+ years of consulting experience preferred
  • Understanding of regulatory processes, understanding of regulatory rules and variations in rules between geographies is critical
  • Familiarity with technology solutions in regulatory such as RIM systems and strong understanding of regulatory data standards is essential
  • SME level knowledge of the Regulatory Intelligence - new regulations like IDMP, regulatory aspects of virtual trials, use of real-world data in designing clinical trials is essential
  • Experience involving interactions with regulatory agencies (FDA, EMA, and PMDA) and participation on industry consortium like (e.g. TransCelerate, PhRMA, RAPS) is desired
Additional skills:
  • Understanding of Pharmacovigilance and Drug Safety processes is highly desired
  • Awareness of systems and advance technologies used in regulatory including cloud technologies, Artificial intelligence and Natural Language processing
  • Strategic thinker with a comprehensive knowledge of the latest industry trend and the ability to bring innovative solutions and analytics to solve challenges in regulatory
  • Executive level presence and communication skills
  • Has published thought leadership pieces
  • Willingness to travel to other global offices, as needed, to work with client or other internal project teams
ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable.

Candidates must possess or be able to obtain work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law.

ZS is committed to providing and maintaining a safe workplace. Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required. Religious/Medical Exemptions can be requested on a limited basis upon hire.

NO AGENCY CALLS, PLEASE.


This job has expired.

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