Manager, Global Regulatory Operations Planner
Company: State of California
Posted on: February 25, 2021
Manager, Global Regulatory Operations Planner Overview:Jazz
Pharmaceuticals is an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. We are continuing to expand our commercial product portfolio
and our research and development pipeline in therapeutic areas that
can leverage our unique expertise.
Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.
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:The Manager, Global
Regulatory Operations Planner will provide expert regulatory
planning capabilities and leadership to the Global Regulatory
Affairs (GRA) Department to ensure the successful delivery of new
capabilities including global submission planning, dossier level
content planning, aggregate safety reports planning, resource
planning in support of product portfolio, and planning for internal
organizational improvement initiatives. This role is expected to
establish an overall planning capability along with building and
leading an appropriately staffed supporting organization. This role
will report directly to the Head of Global Regulatory Operations
giving candidate the opportunity to build something from the ground
up that will enable GRA to better organize and execute on business
objectives. Leverage project management methodologies and tools to
provide guidance to Regulatory teams in achieving operational
excellence. Help teams to gain clarity on issues, interface with
management, and support Jazz's decision making process while
closely monitoring timelines. Act as an expert in regulatory
program management within the Jazz organization. Essential
- Establish a global submission planning capability working with
Global Regulatory Leads and CMC Leads to build portfolio timelines
and to identify key Regulatory Milestones to enable accurate
decision-making, prioritization, and resource mobilization.
- Manage the project planning efforts across GRA including
Regulatory Strategy, Regulatory CMC, Labeling, Regulatory
Operations, and Promotional Review functions.
- Partner with Project Management to ensure a seamless interface
between Regulatory Affairs and the Global Molecule Teams (GMT); and
consolidate and maintain Global Regulatory project management
information needed at the GMTs and EC.
- Works closely with Project Management on schedules, document
delivery, program risk, and mitigating strategies.
- Provide global regulatory submission support to Global
Regulatory Leads for documents such as Annual Reports, Orphan Drug
Applications and applications for expedited pathways e.g.
- Maintain an integrated GRT deliverable projection for
functional planning, in alignment with the GMT and escalate
timeline concerns or obstacles, including risks and issues that may
impact the project and engages appropriate representatives to
manage outcomes. Follows issues through to resolution, ensuring
that all GRT issues arrive at a conclusion or
- Establish a cross-Regulatory risk register for all projects
identifying project challenges, keeping leadership informed of
critical considerations (e.g. resources, team health etc.).--
- Generate and provide Reports for sharing progress and risks
with senior management; identify and escalate highlighting key
risks details around timelines as appropriate.
- Support Global Regulatory strategic initiatives and Regulatory
involvement in related external projects; act as the project lead
where required (e.g. product divestments and in-licensing,
large-scale manufacturing site changes, due diligence activities,
- Consider opportunities for continuous process improvement
across all Regulatory functions.
- 10% to 20% Travel RequiredEducation, Behavioral Competencies,
- Bachelor's Degree and 5+ year's pharmaceutical industry
experience. Previous drug development experience is preferred (e.g.
Regulatory, Clinical, CMC, or other development related
- Experience working within Regulatory Affairs is a plus
- Qualified project management experience; advanced expertise
with project management related software and tools (i.e. MS
Project, SharePoint, etc). PMP certification preferred
- Demonstrated experience in leading decision-making within a
cross-functional, cross-cultural, global team structure in a matrix
- Ability to mentor and develop skills of team members; ability
to articulate and establish business processes.
- 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.
Develops, uses and shares knowledge and uses strong interpersonal
skills to influence and guide others towards the accomplishment of
Jazz's goals and objectives
- Strategic Approach - identify, create, and implement processes
for Regulatory Planning that satisfy business objects of Jazz
- 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: State of California, Philadelphia , Manager, Global Regulatory Operations Planner, Executive , Philadelphia, Pennsylvania
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