Join a forward-thinking and dynamic team committed to excellence in the
pharmaceutical industry
. This position offers an exciting opportunity to contribute to impactful projects that enhance patient care globally.
We are seeking a driven and knowledgeable
Regulatory Strategist
who thrives on navigating complex regulatory landscapes and ensuring compliance for innovative products. As an ideal candidate, you possess a solid understanding of product registration processes and enjoy collaborating with diverse teams to achieve strategic objectives.
* You take full ownership of one or more products throughout their lifecycle.
* You engage in new product introductions and manage existing products consistently.
* You assume strategic regulatory responsibilities to guide products through the regulatory process.
* You support regulatory submissions, including CTD, BLA, NDA, and ensure compliance across the Pfizer portfolio.
* You collaborate with cross-functional teams to deliver high-quality CMC submissions.
* You communicate with regulatory colleagues to address and resolve potential issues.
* You manage timely responses to Board of Health requests and assess post-approval changes.
Additionally, we are looking for a resourceful
Technician
to support our execution-focused activities through standardized tasks. The ideal candidate is a self-motivated individual eager to contribute to team success in a collaborative environment.
* You execute standardized tasks, such as requesting documentation and preparing forms.
* You participate fully in team meetings and integrate yourself within the group.
* You support the team with limited ownership on regulatory activities.
What are we looking for?
* You possess a
Master's degree
in Pharmacy, (Bio)medical sciences, or a similar field.
* You have a
minimum of 3 years of experience
in the pharmaceutical sector, particularly in regulatory affairs, or equivalent experience through a PhD.
* You have strong knowledge of
CMC
and/or
Regulatory Affairs
.
* You demonstrate excellent analytical and communication skills.
* You are capable of working
independently
while being a
team player
.
* You adapt well to a dynamic environment and possess a strong willingness to learn.
* You are fluent in
English
in both written and spoken forms.