Apotex Chemistry Job Opening – Research Associate Post

Apotex Chemistry Job Opening – Research Associate Post

Apotex Chemistry Associate Job. Apotex Pharma Job associate Apotex invites postgraduates Pharma candidates for the post of Associate. Interested and eligible candidates may apply for this post via online mode. For further details check our website Rasayanika.com.

Job Title: Sr. Associate, GRA ABX

Eligibility: MSc or PhD in Chemistry

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

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 submission are prepared and filed in compliance with the relevant regulatory requirements and within scheduled timeframes.
• Support product launch activities from a regulatory perspective.
• Accurately scope out length and difficulty of tasks and projects and ensure timely management of projects and other deliverables.

Apply Online

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