Associate Director, GRA Regional Compliance - EU/Extended EU
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: November 22, 2022
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to the best of my knowledge.Job DescriptionAre you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine?Join us as an Associate Director, GRA
Regional Compliance - EU/Extended EU, based in Zurich. Here, you
will be a vital contributor to our inspiring, bold
- Provide direction and leadership in the identification,
creation, and execution of GRA Compliance initiatives to drive
overall compliance and growth, within Regional and Local Operating
Companies (LOCs), while meeting Takeda corporate objectives.
- Responsible for overseeing with the regions/LOCs, updates and
maintenance of systems linked to regulatory activities e.g.,
Regulatory Information Management System, including the timeliness,
quality and accuracy of information.
- Oversees the implementation of GRA processes, systems and
procedures for GxP processes (e.g. change control,
deviations/CAPAs, etc.) within the region/LOC ensuring execution
- Provides direction and oversight in the management of
submissions and submission activities within the regions/Local
Regulatory Affairs in accordance with local regulations
- Responsible for overseeing global regulatory compliance metrics
at a country/regional level
- Oversight of audits and inspections related to Regulatory
affairs processes globally within the regions/LOCs
- Partners and provides direction with the Regulatory Area Heads
on key Regulatory strategic initiatives and/or issues
- Partner effectively with cross functional teams, in the
proactive identification of key regulatory compliance issues to
determine actionable project proposals and drives them to
- Responsible for demonstrating Takeda leadership behaviors.
- Lead critical GRA projects for GRA Compliance for both
strategic and operational organization, compliance and effective
- Drives compliance within the LOCs linked to regulatory
submissions including the updating and maintenance of systems used
for regulatory activities
- Monitors global regulatory compliance performance within LOC RA
and takes action to address issues within LOC or in GRA
- Oversees the development, implementation and understanding of
regional and local RA training materials related to global
regulatory processes/systems. Delivers training as needed
- Oversees the update and management of all regional/Local
Information/access sites/portals/distributions; and facilitate
creation, implementation and maintenance of communications and
effective change management of RA processes in region/LOCs.
- Oversees inspection and audit activities within the region/LOC
RA. Monitors trends and looks for opportunities to ensure audit and
- Develop strong partnerships with cross functional leadership
within the region and LOCs.
- Lead and engage in efforts to simplify and optimize business
processes and platforms to drive growth and seeks opportunities for
automation of manual processesEDUCATION, BEHAVIOURAL COMPETENCIES
- Bachelor's Degree in a science or business-related field.
- 8+ years of experience in pharmaceutical industry, with 6 years
in Regulatory Affairs, research and development, quality
- People management skills
- Familiarity with Regulatory systems
- Ability to identify proactively and anticipate risk of
non-compliance in a complex environment.
- Demonstrated knowledge of health authorities, regulations,
product approval and lifecycle processes for major markets and of
pharmaceutical and regulatory affairs requirements and practices in
- Practical operational experience of working across disciplines
and across multiple regions. Experience working within a global
team framework and a multi-cultural environment.
- Efficiently/actively manages conflict in a tactful, diplomatic
way, seeking effective solutions for all parties.
- Able to manage both time and priority constraints and to manage
multiple priorities simultaneously.
- Capability to critically analyze complex and/or ambiguous
information and the impact on products and process and to
effectively communicate complex issues both verbally and in
- Excellent analytical, technical and problem-solving skills
- Strong communication skills with the ability to express oneself
clearly and concisely to a variety of audiences. Ability to
understand/analyze/synthesize and communicate to internal/external
- Must be able to lead cross-functional and cross regional teams
and deliver results in a matrix organization.
- Excellent organizational skills and ability to prioritize as
well as Project Management abilities.WHAT TAKEDA CAN OFFER YOUAt
Takeda, we are transforming the pharmaceutical industry through our
R&D- driven market leadership and being a values-led company.
To do this, we empower our people to realize their potential
through life-changing work. Certified as a Global Top Employer, we
offer stimulating careers, encourage innovation, and strive for
excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver Better Health and a Brighter
Future to people around the world.Empowering Our People to
ShineDiscover more at takedajobs.comAt our heart are committed
colleagues. We offer interested people numerous opportunities and
strongly believe in, and promote, diversity, equity and inclusion.
As a company we offer roles based on merit, welcoming candidates of
any gender, age, religious belief, race or ethnic origin or
disability. Our team is growing and for this we need bright minds
with creativity and flexibility - what talent do you have?
LocationsZurich, SwitzerlandWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Associate Director, GRA Regional Compliance - EU/Extended EU, Executive , Cherry Hill, New Jersey
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