Senior Director, Global Regulatory Lead, Oncology - Remote (US/UK)
Company: Disability Solutions
Location: Philadelphia
Posted on: October 18, 2024
Job Description:
If you are a current Jazz employee please apply via the Internal
Career site.Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
and follow @JazzPharma on Twitter. Essential
Functions/Responsibilities:
- As Senior Director, Oncology:
- Represents Global Regulatory Affairs and Drug Safety (GRADS) as
a member of the cross functional teams and governance committees.
Responsible for ensuring collaboration with key internal
stakeholders across various functions to ensure successful planning
and execution of the global regulatory strategy for assigned
program(s).
- Oversight, mentoring and development of Oncology Regulatory
Affairs strategists
- Accountable for the development and maintenance of a global
regulatory strategy plan. In conjunction with Global Regulatory
Team (GRT)/regulatory strategists, ensure that relevant input is
vetted and included in the regulatory strategy in order to deliver
on the Target Product Profile (TPP), regional specific needs,
regulatory environment, regulatory risks and mitigations, and
global submission strategies.
- Identify and assess regulatory risks associated with product
development and recommend strategies to mitigate risks.
- Ensure appropriate representation of regulatory affairs on key
internal program/project teams. Ensure strategic regulatory input
is provided to key development activities and documents, including
clinical protocols, clinical and nonclinical reports and summary
documents, statistical analysis plans, etc. Leverage GRT as
appropriate to ensure appropriate input is provided throughout the
development process.
- Lead Global Regulatory Team (GRT) for assigned molecule(s):
- Facilitate exceptional regulatory team performance by leading
regulatory team meetings and collaborating with regional regulatory
strategists, regulatory sub-function
- representatives, and engaging GRADS leadership for a strong and
broad regulatory strategy and execution of regulatory
deliverables
- Ensure a well-functioning GRT and nurture an environment where
all GRADS team members and functions have a voice
- Pro-actively support the regional strategy leads on the
establishment and maintenance of high-quality working relationships
with regulatory agencies as appropriate for assigned therapeutic
areas and products. Includes effective planning and presentation of
key meetings with Health Authorities to ensure full discussion of
issues and opportunities.
- Develop and implement regulatory strategies to facilitate the
progress of programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams
and assure the progress of projects by providing direction,
solutions and feedback to the teams
- Work with the GRT/regulatory strategists for preparation of
clear and effective global Regulatory submissions e.g., INDs,
NDAs/BLAs, CTAs, MAAs, supplements and other relevant regulatory
filings.
- Depending on the program assignment, the GRL may also serve as
the Regional Strategy Lead
- Responsible for ensuring requirements to maintain marketing
applications and regulatory approvals are achieved within specified
timelines. Oversee and work with regional leads (EU/INT and US) to
ensure consistent approach within molecule and maximize regional
efficiencies.
- Accountable to GRADS and the organization:
- Communicate project updates and risks to Regulatory Leadership
and other stakeholders across the organization. Track regulatory
commitments and ensure timely execution of regulatory
deliverables
- Monitor and analyze appropriate regulatory agency activities
and industry precedence in areas of interest to the company, and
assess impact on programs
- Maintain awareness and communicate with team members regarding
changing regulatory requirements
- Support Global Regulatory Leadership team in developing and
adhering to functional area operational budgets for all
programs
- Mentor, guide, and direct reports in carrying out
responsibilities. Responsible for coordinating activities and
career development of direct reports
- Other duties as assignedRequired Knowledge, Skills, and
Abilities:
- 10 years of experience in Global Regulatory Affairs preferred,
including a minimum of 6 years' experience in drug development and
registration activities; prior experience in relevant therapeutic
area preferred
- Experience interfacing with regulatory agencies and proven
skill at developing and implementing successful global regulatory
strategies
- Thorough knowledge and understanding of regulatory requirements
for pharmaceutical/biological product development and approval in
more than one key region (i.e., US, EU, Japan)
- Creative problem solving and strategizing abilities
- Track record of issue resolution and effective collaboration
with main regulatory authorities, including the FDA; demonstrated
ability to break down complex, scientific content into logical
components.
- Demonstrated leadership success in management of regulatory
activities
- Experience with developing and documenting regulatory
strategies in coordination with clinical plans and marketing
objectives.
- Experience with communicating the regulatory strategy, issues,
and risks in written and verbal format to regulatory senior
leadership team and other governing bodies.
- Ability to broadly represent department functions on project
team in a matrix organization. Demonstrated ability to coordinate
global activities
- Experience in leading and managing matrix teams (3-5 years is
preferred), setting clear direction, holding people accountable and
fostering a collaborative team environment
- Prior line management experience in a global organization
- Excellent verbal and written communication skills and
collaborative interpersonal skills
- Ability to broadly represent department functions on project
team in a matrix organization and demonstrated ability to
coordinate global activitiesRequired/Preferred Education and
Licenses:
- Bachelor's degree with 10 years in Regulatory Affairs
preferred; Master's degree with 6 years' experience or advanced
degree (MD/JD/PhD) with 4 years' experience in Regulatory Affairs
and/or a scientific discipline is preferred.At Jazz, we believe
that effective people leadership is essential to our success. Our
people managers play a vital role in creating an environment where
teams thrive, and individuals reach their full potential. Jazz
invests in people managers to ensure they are equipped to drive
performance, grow individuals and create belonging. As a result,
Jazz people managers champion a culture of collaboration,
inclusion, and belonging; ensuring that everyone feels heard and
valued. They connect with their teams on a personal level,
understanding their unique needs and motivations and providing
personalized support to empower every team member to thrive.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. FOR US BASED CANDIDATES ONLYJazz
Pharmaceuticals, Inc. is committed to fair and equitable
compensation practices and we strive to provide employees with
total compensation packages that are market competitive. For this
role, the full and complete base pay range is: $220,000.00 -
$330,000.00Individual compensation paid within this range will
depend on many factors, including qualifications, skills, relevant
experience, job knowledge, and other pertinent factors. The goal is
to ensure fair and competitive compensation aligned with the
candidate's expertise and contributions, within the established pay
framework and our Total Compensation philosophy. Internal equity
considerations will also influence individual base pay decisions.
This range will be reviewed on a regular basis.At Jazz, your base
pay is only one part of your total compensation package. The
successful candidate may also be eligible for a discretionary
annual cash bonus or incentive compensation (depending on the
role), in accordance with the terms of the Company's Global Cash
Bonus Plan or Incentive Compensation Plan, as well as discretionary
equity grants in accordance with Jazz's Long Term Equity Incentive
Plan.The successful candidate will also be eligible to participate
in various benefits offerings, including, but not limited to,
medical, dental and vision insurance, 401k retirement savings plan,
and flexible paid vacation. For more information on our Benefits
offerings please click here: .
Keywords: Disability Solutions, Freeport , Senior Director, Global Regulatory Lead, Oncology - Remote (US/UK), Executive , Philadelphia, New York
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