Global Regulatory Operations Intelligence Manager
Company: Jazz Pharma
Location: Palo Alto
Posted on: May 4, 2021
Overview:Jazz Pharmaceuticals is a global biopharmaceutical
company dedicated to developing life-changing medicines for people
with serious diseases - often with limited or no options. We have a
diverse portfolio of marketed medicines and novel product
candidates, from early- to late-stage development, in key
therapeutic areas. Our focus is in neuroscience, including sleep
medicine and movement disorders, and in oncology, including
hematologic and solid tumors. We actively explore new options for
patients including novel compounds, small molecule advancements,
biologics and innovative delivery technologies. Jazz is
headquartered in Dublin, Ireland and has employees around the
globe, serving patients in more than 90 countries.We are looking
for the best and brightest talent to join our team. If you're
looking to be a part of a company with an unwavering commitment to
improving patients' lives and being a great place to work, we hope
you'll explore our career openings and get to know Jazz
Pharmaceuticals.Responsibilities:With minimal oversight, the
Manager, Regulatory Intelligence will manage the compilation of
accurate and timely intelligence and manage a cross-functional
process that will result in an impact assessment to Jazz and then
drive the implementation of change actions based on the analysis of
intelligence. This will include using and developing appropriate
information and intelligence analysis methodologies and processes
to support delivery of the objectives that align with Jazz
priorities. The Manager, Regulatory Intelligence will regularly
prepare and present regulatory intelligence across departments and
to senior management. This role will also be a key a contributor to
the design, development, and implementation of a Regulatory
Intelligence platform and associated business processes. Essential
- Research, collect, organize and maintain files on regional and
global regulatory intelligence and other related information for
all markets where Jazz has a presence or is planning a
- Apply industry standard methodologies and tools to conduct
intelligence analysis and profiling to identify emerging compliance
risks, trends, and opportunities.
- Deliver advice and contribute to effective strategy development
concerning regulatory submissions, approval pathways and compliance
activities that affect Jazz assets.
- Initiate electronic workflow to route newly identified
intelligence to appropriate functions to thoroughly assess
potential impact to Jazz and assign actions to ensure a closed
looped mechanism for identifying, assessing, and taking action on
- Initiate change controls and act as a project manager to ensure
implementation of identified actions.
- Contribute expertise to a cross-functional team that defines
and oversees the standardization and implementation of
systems/processes to monitor the regulatory environment for changes
that may have an impact on Jazz's projects, objectives, and
- Facilitate and lead presentations, discussions and forums up to
senior management level, which provide intelligence and analysis on
emerging trends and potential risks.
- Promote an intelligence culture that supports a targeted
approach to compliance.
- Engage and develop tactical/operational partnerships to enhance
the building and sharing of intelligence across Jazz R&D and
- Ensure alignment with other Regulatory Intelligence initiatives
across Jazz, primarily Pharmacovigilance.
- Develop formal process for submitting Jazz comments to agency
requests for input to proposed rule changes, legislation, and
- Author, review, and approve applicable SOPs, Work Instructions,
Best Practices, Policies, and Internal Guidance.Education,
Behavioral Competencies, and Skills:
- Bachelor's Degree is required. Science, Engineering, Computer
Science or business-related field preferred.
- Knowledge and a sound understanding of regulatory and
compliance functions and purpose.
- Sound knowledge of industry standard sources, tools and
methodologies for collecting and organizing literature, news and
intelligence; preferably Cortellis, InfoDesk, StoryTeller, Embase,
PubMed, and RightFind.
- Good level of competence in the use of specialized intelligence
- High level of critical reasoning skills and a well-developed
intuition about appropriate approaches, and risks.
- Ability to coordinate information from various internal and
- Proven ability to communicate clearly and present key
information objectively; demonstrated ability to clearly
communicate/ prepare presentations for management.
- Analytical and Problem-Solving Skills - ability to identify the
critical issues of problems or opportunities using appropriate
information; determines the causes and possible solutions to the
problem. Excellent ability to understand complex issues and propose
creative and achievable solutions.
- Leadership Skills - ability to lead and motivate team members,
without direct line management responsibility. Develops, uses and
shares knowledge and uses strong interpersonal skills to influence
and guide others towards the accomplishment of Jazz's goals and
- Strategic Approach - identify, create, and implement processes
for Regulatory Planning that satisfy business objects of Jazz
globally.Presentation skills - create and deliver presentations
with appropriate messaging and focused recommendations. Jazz
Pharmaceuticals is an equal opportunity/affirmative action employer
and all qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, national
origin, disability status, protected veteran status, or any
characteristic protected by law.
Keywords: Jazz Pharma, Palo Alto , Global Regulatory Operations Intelligence Manager, Executive , Palo Alto, California
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