Regulatory Affairs pharmaceutical products –Manager - English - On site Johannesburg! (LIF016395)
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Full Job Description
Job Description - Regulatory Affairs pharmaceutical products –Manager - English - On site Johannesburg! (LIF016395)
Regulatory Affairs pharmaceutical products –Manager - English - On site Johannesburg! - LIF016395
Genpact (NYSE: G) is a
global professional services and solutions firm delivering outcomes
that shape the future. Our 125,000+ people across 30+ countries are
driven by our innate curiosity, entrepreneurial agility, and desire to
create lasting value for clients. Powered by our purpose – the
relentless pursuit of a world that works better for people – we serve
and transform leading enterprises, including the Fortune Global 500,
with our deep business and industry knowledge, digital operations
services, and expertise in data, technology, and AI.
Inviting
applications for the role of Regulatory Affairs pharmaceutical
products –Manager - English - On site Johannesburg!
You should have
minimum Relevant years of experience in regulatory affairs with must
knowledge of current regulatory guideline in South Africa Market.
Responsibilities
• In this role, you will be responsible for
all local regulatory affairs lifecycle management (LCM) and
maintenance activities for assigned products, including but not
limited to the following:
• Variations (Administrative, Labeling,
CMC, Safety, dossier harmonization): Submission strategy / provide RA
Assessment through change management system / CMC Assessment /
Timelines / Management of local RA requirements including
implementation tasks (e.g. including grace period for supply
continuity), example external compendia. Coordinate artwork changes
for submission and implementation (triggered due to LCM activities).
Communicates & collaborates effectively with different groups both on
the business & IT side, including senior stakeholders – ability to
articulate complex scenarios succinctly and targeted to the group
•
Update Local PI
• Primary contact for Local Health Authority on
delegated products
• Ensure customer success throughout the
engagement
Qualifications we seek in you!
Minimum
Qualifications
• Bachelor’s degree, preferably in Pharmacy,
Medicine, Chemistry, or related Life science discipline required with
relevant experience in the pharmaceutical industry.
• Mandatory
Knowledge of EMEA/South Africa regulation and well adheres of English
language
• Effective time management and organizational skills to
efficiently manage multiple time-sensitive assignments
simultaneously
• Demonstrates deep understanding of the business
value of quality and compliance, and the implications and risks of
non-compliance. Adjusts behaviors to drive high quality
deliverables
• Demonstrates the ability to independently solve
trouble shoot problems that arise within job responsibilities and
expectations, and takes a new perspective using existing
solutions
• Effectively communicates difficult issues both verbally
and in writing to build alignment around a complex situation and
process.
• Flexibility to adapt to a changing environment, keeping
current with new and updated processes and procedures
Preferred Qualifications/ Skills
• Enthusiasm & confidence
• Adhere
to our principles and values.
• Time Management skills.
What can
we offer?
Attractive salary and benefits such as Medical
Aid, Retirement and risk benefits
Work in a multicultural
environment;
Various trainings (technical & soft skills);
Development opportunities in a growing multinational company;
Genpact is an Equal Opportunity Employer and considers
applicants for all positions without regard to race, color, religion
or belief, sex, age, national origin, citizenship status, marital
status, military/veteran status, genetic information, sexual
orientation, gender identity, physical or mental disability or any
other characteristic protected by applicable laws. Genpact is
committed to creating a dynamic work environment that values diversity
and inclusion, respect and integrity, customer focus, and innovation.
For more information, visit . Follow us on Twitter, Facebook,
LinkedIn, and YouTube.
Furthermore, please do note that Genpact
does not charge fees to process job applications and applicants are
not required to pay to participate in our hiring process in any other
way. Examples of such scams include purchasing a 'starter kit,' paying
to apply, or purchasing equipment or training.
Regulatory Affairs Pharmaceutical Products –Manager - English - On Site Johannesburg! (lif016395)
Genpact
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