Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Oncology - Remote
Company: Takeda
Location: Somerville
Posted on: June 16, 2022
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Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Noticeand Terms of Use. I further attest that
all information I submit in my employment application is true to
the best of my knowledge.Job DescriptionAre you looking for a
patient-focused company that will inspire you and support your
career? If so, be empowered to take charge of your future at
Takeda. - Join us as a Senior Director, Global Regulatory Portfolio
Lead, Global Regulatory Affairs in Cambridge remotely.Here,
everyone matters and you will be a vital contributor to our
inspiring, bold mission. As an Senior Director working on the
Global Regulatory Affairs Oncology team, you will be empowered to
provide leadership and development to global regulatory leads to
ensure innovative and robust global regulatory strategies are
developed to maximize regulatory success and minimize time to
approval, and a typical day will include: -OBJECTIVES/PURPOSE
Provides leadership and development to global regulatory leads to
ensure innovative and robust global regulatory strategies are
developed to maximize regulatory success and minimize time to
approval.Develops best practices and creates a strong regulatory
community across the broader Global Regulatory Affairs (GRA)
organization.Serves as an influential leader within Takeda and
external to Takeda, contributing to cross-functional initiatives
and influencing the field as applicable.ACCOUNTABILITIES The Senior
Director will be responsible for managing direct reports and
overseeing all global and US submission for an assigned portfolio
of projects . These include ensuring that the direct reports have
defined, developed and clearly communicated appropriate global
strategies to maximize global regulatory success. The role may
serve as an interim GRL on a global project team on a as needed
basis.Partner with direct reports to ensure global market access
consideration are being addressed - and provide senior strategic
input to interactions with joint regulatory/health agency/HTA
bodies on product specific value evidence topics, as
applicable.Ensures line management and key stakeholders are
apprised of developments that may impact regulatory success,
exercising sound judgement and communicating in a professional and
timely manner. Demonstrates ability to anticipate risks and
responsible for developing solutions to identified risks and
discussing with direct reports and management; understands
probabilities of technical success for the solutions.Effectively
represent the Global Regulatory Affairs (GRA) function in senior
level interactions at internally governance technical review
committees, key global health authority meetings and external
partners.Accountable for working with regulatory regional leads,
other functions and vendors to ensure global regulatory submissions
are provided to local Takeda affiliates in compliance with local
regulations and to maintain compliance for products.Participates
with influence in or leads departmental and cross-functional
task-forces and initiatives. - Influence non-direct reports within
Therapeutic Area, across GRA and across R&D.Provide regulatory
strategy support to diligence for licensing opportunities as
appropriateMonitor and anticipate trends that impact both the
regulatory and access environments to strengthen product
development plan(s) and adopt regulatory strategies in a timely
manner.Responsible for demonstrating Takeda leadership
behaviors.DIMENSIONS AND ASPECTS Technical/Functional (Line)
ExpertiseComprehensive understanding of the pharmaceutical industry
and global regulatory strategy experience.LeadershipDemonstrated
ability to work across functions, regions and culturesFunctional
level leadership with the ability to inspire, motivate and drive
resultsExcellent communicator, able to persuasively convey both
ideas and data, verbally and in writingProven skills as an
effective team player who can engender credibility and confidence
within and outside the companyAbility to distil complex issues and
ideas down to simple comprehensible termsDemonstrates leadership
presence and confidenceEmbraces and demonstrates a diversity and
inclusion mindset and role models these behaviors for the
organizationBuilds teams across functions and geographies with
individuals who have the right skills and experience to deliver on
key organizational initiatives.Invests time in helping others to
enhance their skills and perform at a higher levelDecision-making
and AutonomyDecision making responsibilities:Provide input to
highly complex decisions that impact the functional areaAccountable
for decision making for designated functionAbility to seek diverse
input from multiple constituents and stakeholders to drive
innovative solutionsAbility to incorporate feedback and ensure
decisions are implemented swiftly to yield flawless execution
-Accountable for providing input to and implementing vision and
strategy for designated scope-making, complexity of decisions,
impact of decisions, problem-solving)InteractionEffectively
navigates the changing external and internal environment and leads
others through change by creating and inspiring and engaging
workplaceCultivates a broad network of relationships throughout
Takeda, with affiliates and external partners, in the industry and
area of expertise.Effectively represents function in negotiations
with the ability to resolve conflict in a constructive
mannerAbility to build strong relationships and collaborate
effectively with other interfacing Takeda
functionsInnovationForward thinking with the ability to recommend,
influence and implement organizational change and continuous
innovationComfortable challenging the status quo and bringing
forward innovative solutionsAbility to take risks implementing
innovative solutions, accelerating time to marketIdentifies
opportunities and anticipates changes in the business landscape
through an understanding and ongoing assessment of the environment
affecting the business.Role models respect and inclusion, creating
a culture that fosters innovationComplexityAbility to work in a
global ecosystem (internal and external) with a high degree of
complexityDeep expertise requiredAbility to see and understand
broader, enterprise level perspective -EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS:Advanced degree in a scientific subject
area (e.g. MSc, PhD, PharmD, MD) with global oncology regulatory
experience preferred. - BA accepted.12+ years of pharmaceutical
industry experience. - This is inclusive of 10 years of regulatory
experience or combination of 8+ years regulatory and/or related
experience. -Preferred experience in reviewing, authoring, or
managing components of regulatory submissions. -Solid working
knowledge of drug development process and regulatory requirements.
- Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
-Understand and interpret complex scientific issues across multiple
projects as it related to regulatory requirements and
strategy.Understands and interprets scientific data as it relates
to regulatory requirements and strategy for assigned projects and
provides knowledge and expertise to guide team in established and
building appropriate global regulatory strategy.Strong oral and
written communications, managing and adhering to timelines,
negotiation skills, integrity and adaptability.Demonstrates
acceptable skills with increasing independence in the area of
regulatory strategy such as understanding broad concepts within
regulatory affairs and implications across the organization and
globally; proactively identifies regulatory issues; offers
innovative -solutions and strategies, including risk mitigation
strategies.Must work well with others and within global teams.
-Able to bring working teams together for common
objectives.Acceptable and independent skills in the area of
regulatory strategy such as understanding broad concepts within
regulatory affairs and implications across the organization and
globally; proactively identifies regulatory issues; offers creative
solutions and strategies, including risk mitigation strategies.WHAT
TAKEDA CAN OFFER YOU:401(k) with company match and Annual
Retirement Contribution PlanTuition reimbursementCompany match of
charitable contributionsHealth & Wellness programs including onsite
flu shots and health screeningsGenerous time off for vacation and
the option to purchase additional vacation daysCommunity Outreach
ProgramsLocation and Salary Information: "This position is
currently classified as "remote" in accordance with Takeda's Hybrid
and Remote Work policy."Base Salary Range: $240K-$270K based on
candidate professional experience level. Employee may also be
eligible for Short Term and/or Long Term incentive benefits.
Employees are eligible to participate in Medical, Dental. Vision,
Life Insurance, 401(k), Charitable Contribution Match, Company
Holidays, Personal & Vacation Days, Student Loan Repayment Program
and Paid Volunteer Time OffIf candidate is not eligible for any
benefits or other comp., those can be excluded "This posting is
made in compliance with Colorado's Equal Pay for Equal Work Act,
C.R.S. - 8-5-101 et seq."Empowering Our People to ShineLearn more
at takedajobs.com.No Phone Calls or Recruiters Please.#LI-VMEEO
StatementTakeda is proud in its commitment to creating a diverse
workforce and providing equal employment opportunities to all
employees and applicants for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, gender
expression, parental status, national origin, age, disability,
citizenship status, genetic information or characteristics, marital
status, status as a Vietnam era veteran, special disabled veteran,
or other protected veteran in accordance with applicable federal,
state and local laws, and any other characteristic protected by
law.LocationsNew York - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Somerville , Senior Director, Global Regulatory Portfolio Lead, Global Regulatory Affairs - Oncology - Remote, Executive , Somerville, Massachusetts
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