Artwork Coordinator Project Leader - Mississauga, Canada - GSK

GSK

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Site Name:
Canada - Ontario - Mississauga

Posted Date:
Apr

Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.

As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.

These responsibilities include some of the following:

Responsible for chemistry, manufacturing and controls of regulatory matters relating to registrations and/or maintenance of business activities
Interact with colleagues in other global functions and Regulatory Affairs to deliver high quality dossiers, documents and materials to local Regulatory Affairs in accordance with business priorities
Ensure close partnership with authors, assuring technical congruency and regulatory compliance
Provide evaluations for potential changes as requested and follow up to ensure regulatory compliance and completion of appropriate internal compliance records
Effectively communicate regulatory requirements and guidelines, facilitating timely and complete submissions
Develop uptodate knowledge to guidelines and regulatory requirements, as well as technical trends

_ 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):
1+ years' experience in regulatory affairs including chemistry, manufacturing and controls, and over the counter experience

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

Knowledge of regulatory submissions to markets
Ability to ensure compliance standards and key performance indicators are met
Regulatory expertise in knowledge of the regulatory life cycle
Ability to interact at many levels
Technical knowledge

_ Why GSK?_

Our values and expectations
are at the heart of everything we do and form an important part of our culture.

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 wellbeing
Building strong relationships and collaboration, honest and open conversations.
Budgeting and costconsciousness

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy.

We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine.

We feel strongly that this is the best way to help protect those we value most:
our employees, families, communities and the patients and consumers we serve.

To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices.

In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors' offices and dentists' offices will need to be fully vaccinated against COVID-19.

Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

**Important notice to Employment businesses/ Agencies