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Regulatory Affairs

HEAD GLOBAL POLICY AND REGULATORY INTELL

  • 타이틀 HEAD GLOBAL POLICY AND REGULATORY INTELL
  • 부서 Regulatory Affairs
  • 하위 기능 Regulatory Affairs
  • 위치 Spring House, Pennsylvania, United States; Raritan, New Jersey, United States; Titusville, New Jersey, United States
  • 게시
  • 참조 2306109209W
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묘사

The Janssen Pharmaceutical company of Johnson & Johnson is recruiting for a VP, Global Policy and Intelligence role within the Global Regulatory Affairs organization. The primary location for this role is Spring House, PA, but it can also be based in Raritan, NJ, or Titusville, NJ. Additionally remote work options may be considered on a case-by-case basis and if approved by the Company.

Company background & culture

Johnson & Johnson (J&J) is the world’s most broadly-based healthcare company and a provider of related services for the pharmaceutical and medical tech/device markets. J&J employs approximately 130,000 people worldwide, deployed in more than 250 operating companies in 60 countries. Products are sold throughout the world and serve a broad segment of medical needs ranging from baby care, first aid, and hospital products to prescription pharmaceuticals, medical devices and products relating to family planning, dermatology, and feminine hygiene.

J&J and its subsidiaries built the most comprehensive base of health care businesses in the world, generating more than 70% of company revenues from No. 1 or No. 2 global leadership positions in their respective markets. J&J’s consistent performance for 132 years enabled the company to deliver an exceptional track record of growth that few, if any, companies can claim: 28 consecutive years of adjusted earnings increases and 50 consecutive years of dividend increases. J&J is one of only two U.S. industrial companies that still commands a Triple A credit rating by both Standard and Poor’s and Moody’s.

Within the Pharmaceuticals sector, Global Regulatory Affairs is a critical strategic partner and core capability. With more than 1,000 employees deployed in Europe, North America, Latin America, Asia/Pacific, the Middle East and Africa, Global Regulatory Affairs fosters relationships with health authorities around the world, and delivers innovative healthcare solutions to patients.

Responsibilities:

The Vice President Global Regulatory Policy and Intelligence is responsible for leading, developing, and driving the J&J Pharmaceutical Sector External Global Regulatory Policy and Internal Intelligence efforts across the pharmaceutical sector, with additional critical input on relevant issues for the Medical Tech Sector. This position provides high quality strategic input and tactical support to J&J Senior Pharma Leaders, global project teams and the larger regulatory community by applying strong expertise and customer focus to shape key regulatory healthcare policies by

  • collaborating with senior managers within health authorities and trade associations,
  • leading the Global Pharmaceutical Commenting System,
  • driving strategic capabilities for regulatory information and knowledge management services,
  • providing current, reliable, and value-added intelligence and information,
  • developing processes that govern the creation, dissemination and retention of knowledge and drive product strategic development plans for marketing applications,
  • building and establishing and communicating best practices for interactions with our external customers including health authorities, trade associations and key opinion leaders,
  • developing and delivering advocacy and influencing activities, in partnership with internal colleagues from GRA and leaders in GA&P, Legal, Commercial, and Business departments,
  • monitoring and anticipating regulatory, scientific and pertinent legal issues and assessing for potential impact on the Company,
  • fostering innovation,
  • contributing to a Credo-based environment.

Overall responsibilities include:

  • Serve as a recognized external regulatory leader and influential spokesperson, in support of J&J’s global regulatory initiatives
  • Lead a global team consisting of policy and technical experts and manage a budget that includes training, travel, regulatory information subscriptions.
  • Regulatory lead for cross-pharma policy development.
  • Shape key regulatory healthcare policies by collaborating with:
  • key senior leaders within health authorities, including FDA Commissioner and Deputy Commissioners, Office and Division Directors as well as EMA Executive Director and Working Party Leaders.
  • trade associations, including support and advice at all levels of BIO, PhRMA and EFPIA committees and select associations in AP and LA regions to align J&J representatives
  • Enhance communications with health authorities through active facilitation and leveraging best practices in support of regulatory teams and to resolve agency related issues related to the J&J portfolio consisting of more than 100 large and small molecule products
  • Provide leadership directly with regulatory authorities and through partnerships with trade associations and/or individual biopharmaceutical companies to build capabilities for:
  • Emerging technologies; e.g., regenerative medicines, digital health applications, drug device combinations, precision medicine, microbiome
  • Emerging drug development tools and practices; e.g., Patient Focused Drug Development, Model Informed Drug Development, Integrated Evidence Generation
  • Responsible to, and be a member of senior leadership teams including:
  • Global Regulatory Affairs
  • Cross Sector Policy Council
  • Other teams as relevant

Business Environment and Context:

Global Regulatory Affairs (GRA) is a strategic partner and core capability in Research & Development, the Government Affairs Organization, Law Department, commercial sector, and with cross sector counterparts in the MEDTECH franchise. It is focused on maximizing and maintaining the value of our products and solutions throughout their life cycle. GRA is a trusted collaborator with worldwide regulatory authorities. Through establishing relationships with health and regulatory authorities around the world, and speaking directly to the doctors, nurses, patients and caregivers who utilize J&J’s product first-hand, GRA is able to learn and adapt to the ever-evolving and changing health care environment to ensure they are meeting the needs and demands of consumers, industry stakeholders, and internal and external collaborators.

GRA’s activities focus on driving regulatory strategy for the greater J&J organization, and in doing so help to build and protect the reputation of the company in relation to compliance, quality, values and trustworthiness. GRA works to interpret regulatory requirements, obtain regulatory approvals, and influence government policies, so that innovative products will be made available to more patients.

The culture and mindset is based on three pillars:

  1. Problems are solvable – GRA employees think in terms of “Here’s how we can, not why we can’t!” using a mix of experience with drive to solve business challenges and make complex initiatives easy;
  2. A trusted partner – GRA works collaboratively with partners to provide strategic insights and different perspectives, using deep expertise and valuing accountability, adaptability and collaboration; and
  3.  Fingerprinting the future – GRA professionals are intrigued by what’s ahead and enable people to seek opportunities in a dynamic environment, encouraging an innovative mindset, an external focus, strong leadership and global awareness.

GRA provides an innovative environment that promotes both teamwork and significant personal accomplishment. There is a strong commitment to professional growth and ongoing learning, which is an important differentiator in the regulatory industry.

Key internal & external relationships

Internal:

  • Global Regulatory Affairs
  • Research and Development
  • Legal
  • Commercial
  • Cross Sector
  • Corporate

External:

  • Global Health Authorities
  • Trade Associations
  • Government Bodies
  • Partner Companies
  • Technology Companies
  • Patient Organizations
  • Key Opinion Leaders

자격

Preferred BUSINESS & LEADERSHIP EXPERIENCES:

  • Has a track record of successful global registrations and effective life cycle management with focus on quality, compliance and efficiency.
  • Has a track record of successfully leading and developing virtual global teams.
  • Has an established network with regulatory authorities globally.

Education and experience

  • Advanced degree required (Masters in one of the Health Sciences, PhD, MD, JD)
  • A minimum of 15 years in Regulatory Affairs, Drug Development or Research & Development in Pharmaceutical Industry or a Regulatory leadership role in a Health Authority
  • Extensive experience in the development and execution of global Regulatory strategies, the drug development process, Regulatory compliance, Regulatory strategy for product lifecycle management and establishing productive working relationships with Health Authorities
  • Experience with influencing policy and partnering with Health Authorities
  • Seasoned business leader, decision maker and constructive challenger
  • Ensures a high level of compliance, as well as operational excellence and efficiency
  • Global management experience is a must

 

Disclaimer: This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job; it is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations, and for establishing performance standards. The incumbent shall perform all other functions and/or be cross-trained as shall be determined at the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

The anticipated base pay range for this position in the US is $199,000 to $365,700.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long-term incentive, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.