Apotex Sr. Associate,
GRA ABX MSc or PhD in Chemistry, Chemical Engineering, Biotechnological Process
Engineering, Molecular Biology
Apotex is a proudly
Canadian, global pharmaceutical company that produces high-quality, affordable
medicines (both generic and innovative pharmaceuticals) for patients around the
world. We are the 7th largest generic pharmaceutical company globally with more
than 12,000 employees and estimated sales of approximately $3 billion. Our
fully integrated operation is comprised of four lines of business:
Global
Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and
ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex
can produce up to 24 billion dosages per year. We produce 300 medicines in
4,000 dosages and formats that are exported to 115 countries. Apotex will spend
$2 billion over the next 10 years on research and development.
Job Summary
Responsible for the
preparation, compilation, and submission of dossiers for registration of Apotex
Biopharmaceutical products in Canada.
This involves planning, managing, writing, and/or reviewing the
activities and documents for the preparation of the required submissions. Strong links need to be established with all
Apotex departments involved in the project and with all
development/manufacturing external partners to ensure dossiers are compiled,
submitted and approved in an efficient and timely manner. Ability to read,
analyze and interpret technical documents. Responsible for regulatory
activities related to new product submissions, product launches and marketed
products, including change control assessments and post-approval filings.
Job Responsibilities
Due diligence
activities for new opportunities. Review
and advise on adequacy of dossiers/information/data provided in support of new
in-license biosimilar submission opportunities for the Apo-Biologix portfolio,
from the regulatory perspective.
Prepare and submit high
quality regulatory submissions for biosimilar products in line with targeted
project timelines.
Interact with internal
and external partners as necessary to ensure the appropriate information is
obtained for submission.
Create, manage and maintain
detailed regulatory submission timelines to ensure that all elements of
submission dossier are completed in a timely manner.
Coordinate with
relevant internal and external subject matter experts and external partners to
respond to regulatory agency deficiencies.
Life Cycle management:
perform change control assessments, and prepare/submit necessary post approval
change submissions.
Ensure that post
approval submissions are prepared and filed in compliance with the relevant
regulatory requirements and within scheduled timeframes.
Support product launch
activities from regulatory perspective.
Accurately scope out
length and difficulty of tasks and projects and ensure timely management of
projects and other deliverables.
Job Requirements
MSc or PhD in Chemistry,
Chemical Engineering, Biotechnological Process Engineering, Molecular Biology
or similar.
Minimum 5 years
experience in the pharmaceutical industry with focus on Biologics (specifically
in regard to analytical similarity, process development and/or manufacture,
immunogenicity), dossier development and technical writing
Detailed knowledge of
Canadian biosimilar regulatory requirements is preferred. Knowledge of
regulatory requirements for biosimilars in multiple jurisdictions is an asset
e.g. TPD, FDA, EU,etc.
Excellent oral/written
communication, leadership, organizational and interpersonal skills
Computer literate. Familiarity with IT systems, e.g. electronic
submission systems like Docubridge
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