Minimum Level Job
related Experience :
10 + years of
experience in Regulatory Affairs in CMC variations for or related
responsibilities for Rx and Vx of which 2+ years managing teams delivering CMC
outputs
Managed a Variation
team of more than 5 people that successfully delivered outputs to time and
quality over a sustained period
Worked within a
global organization across different geographical locations
Successfully
performed within a regulated or quality-critical environment
Direct or indirect
experience of regulatory processes associated with gaining and maintaining
product registrations for both Investigational and Licensed Products
Successful and sustained
delivery of a significant number of variation packages including a broad range
of submission types across EU/US and International markets
Key Responsibilities:
Manage HR aspects for
a team of direct reports including recruitment, training and development
Manage and take
accountability of workload within assigned team and work with other team leads
within functional area to address resource challenges
Build CMC
competencies in team and coach the team when needed.
Responsible for
tracking/reporting on team performance against key indicators
Provide peer review
and quality check support as requested and able
Serve as point of
escalation for team members
Maintain a workload
in area of responsibility; provide support to team in problem solving
Participate in
quality or continuous process improvement activities related to area of
responsibility or as requested
Maintain appropriate
organizational networks
Recognizes matters
that affect corporate or agency policies and escalates issues with high
business
impact or risk.
Understands
regulations, guidelines, procedures and policies relating to registration and
manufacturing of pharmaceutical products/registration data
management/submission format to expedite submission, review and approval of
global applications.
Coach and Advise and
assist authors with more complex variations or non-routine assignments
Along with team
management the individual will also deliver individual projects
Independently and
confidently executes agreed assignments strategy
Independently manages
multiple project assignments in the area of responsibility simultaneously;
assignments will range in complexity but more complex work is expected
Independently
completes data assessment/data maintenance tasks/complex submission packages to
ensure output is fit for purpose.
Why you?
Basic Qualifications:
We are looking for
professionals with these required skills to achieve our goals:
Bachelor’s degree in
Pharmaceutical or Life Sciences or equivalent regulatory experience (consult
manager on equivalent regulatory experience)
Why GSK?
Our values and
expectations are at the heart of everything we do and form an important part of
our culture.
These include Patient
focus, Transparency, Respect, Integrity along with Courage, Accountability,
Development, and Teamwork. As GSK focuses on our values and expectations and a
culture of innovation, performance, and trust, the successful candidate will
demonstrate the following capabilities:
Operating at pace and
agile decision-making – using evidence and applying judgement to balance pace,
rigour and risk.
Committed to
delivering high quality results, overcoming challenges, focusing on what
matters, execution.
Continuously looking
for opportunities to learn, build skills and share learning.
Sustaining energy and
well-being
Building strong
relationships and collaboration, honest and open conversations.
Budgeting and
cost-consciousness
Our goal is to be one
of the world’s most innovative, best performing and trusted healthcare
companies.
We believe that we all bring something unique to GSK and when we
combine our knowledge, experiences and styles together, the impact is
incredible. Come join our adventure at GSK where you will be inspired to do
your best work for our patients and consumers. A place where you can be you,
feel good and keep growing.
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