Manager Oncology GRA
Company: GlaxoSmithKline
Location: Rockville
Posted on: August 4, 2022
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Job Description:
Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland
- Rockville, USA - Massachusetts - Waltham Posted Date: May 18 2022
We have exciting career opportunities in Global Regulatory Affairs
for Manager level individual strategic contributors to support
exciting and innovative research across the Oncology therapies. We
have been actively exploring ways to help, with our science and
expertise, alongside protecting the health and wellbeing of our
people and managing our global supply chains to support patients
and consumers who depend on our products. This represents an
exciting opportunity to be part of GSK Pharma R&D, who is
committed to innovative scientific research and discovery to help
people do more, feel better, live longer. In this role, you will
provide regulatory strategic leadership and support for early
and/or late-stage Pharmaceutical R&D portfolio. Our Global
Regulatory Affairs (GRA) Therapeutic Group (part of the Global
Regulatory and Quality organization in Pharmaceutical R&D)
develops global regulatory strategies to deliver our innovative
portfolio. We are strategic partners with Pharmaceutical R&D
and Commercial in delivering and maintaining our product pipeline,
whilst complying with Health Authority regulations. We share
learnings and best practices to foster continuous improvement. We
strive to shape the evolving regulatory environment and influence
policies/guidelines in areas that are key priorities for GSK. We
believe in life-long learning and developing our people. We take
ownership of our development, as driven by on-the-job experiences,
interactions with people, formal instruction and access to learning
resources, with support from our leaders. Purpose Ensure the
development of appropriate global and/or regional regulatory
strategy(s) and their execution for assigned asset(s) consistent
with Medicines Development Strategy /Integrated Asset plan to
ensure the development program meets the needs of the key markets
identified and the Medicines Profile. This goal has to be achieved
while ensuring compliance with both internal GSK process / policy
and with appropriate regulatory requirements to deliver the best
possible labeling to meet the Medicine Profile, commensurate with
the available data Accountable to GRL and Global Regulatory TA Head
for development of appropriate regional regulatory strategy(s) and
for delivery according to plans. In conducting role, planning will
be on a multiple year horizon, with delivery requiring extensive
matrix working within GSK to VP level and representing GSK with at
least the local regulatory agency. Work with the Early/Medicine
Development Team (EDT/MDT) or GRL, to ensure a robust regulatory
strategy is in place to support the development program to meet the
needs of the key markets identified in the Integrated Asset plan
and the Medicine Profile. Work closely with local / regional
commercial team to secure best possible labeling commensurate with
the available data. Lead interactions with local / regional
regulatory authorities. In performing the role, the job holder will
be responsible for: Proactively developing regulatory strategy that
will deliver the needs of the local region(s), taking in to account
the needs of other regions globally. Implementation of the regional
strategy(s) in support of the project globally Lead regulatory
interactions and the review processes in local region Ensuring
appropriate interaction with global/regional counterparts and
commercial teams in local region Ensuring compliance with global/
regional requirements at all stages of product life Ideally assess
precedent, regulatory intelligence and competitive environment from
a regulatory perspective for the region and the impact this will
have on the regulatory strategy for an asset Good communication
skills, especially in writing. Capable of delivering key
communications with clarity, impact, and passion Ideally good
listening and comprehension skills; proactive in identifying
potential issues and escalating them accordingly Ability to foster
strong matrix working. Facilitates dialogue between team and matrix
members to contribute their ideas. Capable of developing and
recommending strategies for change. Capable of identifying project
or team issues in advance and seeking necessary help and support to
resolve. Ability to derive creative solutions to regulatory
problems, while balancing the expectations of Agencies and ensuring
compliance with regulation in all regions. Recognizes potential
long-term issues for projects. Ability to make sound decisions and
in doing so, the job holder will use a range of sources and weight
benefits and risks before making important decisions. Shows a
constant focus on improving performance and excellence in all
tasks. Challenges and questions ways of working to seek improved
process. Seeks to raise levels of performance by establishing or
improving process Developing personal networks, within GSK and
capable of using them to secure appropriate support and outcome for
a project. Why You Basic Qualifications: Bachelor's degree or
preferably PhD in biological or healthcare science 5 years'
Experience of all phases of the drug development process in
regulatory affairs preferred 5 years' experience of leading
regional development, submission and approval activities in local
region(s) 5 years' Experience with clinical trial and licensing
requirements in all major countries in the region and ideally
knowledge of other key Agency processes globally. Preferred
Qualifications: Knowledge of relevant therapy area, and ability to
further develop necessary specialist knowledge for the product or
area of medicine Minimum 5+ years of global regulatory experience
in drug development and life-cycle management. Prior experience
leading health authority interactions; experience leading or
supporting major submissions from filing through approval
Demonstrated leadership capabilities and ability to think
strategically Demonstrated ability to integrate regulatory science
with scientific/clinical knowledge Demonstrated track record of
working in a global team and matrix organization Demonstrated
negotiation skills across levels within an organization and with
external stakeholders Experience in managing multiple projects and
proactively plan Why GSK At GSK, we have already delivered
unprecedented change over the past four years, improving R&D,
becoming a leader in Consumer Health, strengthening our leadership,
and transforming our commercial execution. Now, we're making the
biggest changes we've made to our business in over 20 years. We're
on track to separate and create two new companies in 2022: New GSK
with a leading portfolio of vaccines and specialty medicines as
well as R&D based on immune system and genetics science; and a
new world-leading consumer healthcare company of loved and trusted
brands. With new ambition comes new purpose. For New GSK, this is
to unite science, technology and talent to get ahead of disease
together - all with the clear ambition of delivering human health
impact; stronger and more sustainable shareholder returns; and as a
new GSK where outstanding people thrive. Getting ahead means
preventing disease as well as treating it. How we do all this is
through our people and our culture. A culture that is ambitious for
patients - so we deliver what matters better and faster;
accountable for impact - with clear ownership of goals and support
to succeed; and where we do the right thing. So, if you're ready to
improve the lives of billions, join us at this exciting moment in
our journey. Join our challenge to get Ahead Together. *LI-GSK If
you require an accommodation or other assistance to apply for a job
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Keywords: GlaxoSmithKline, Rockville , Manager Oncology GRA, Healthcare , Rockville, Maryland
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