Apotex is the largest Canadian owned pharmaceutical company, and the largest producer of generic medicines in the Country. We have an incredible team of bright, passionate, and committed individuals who are proudly dedicated to our mission of bringing a growing array of high quality, affordable medicines to the healthcare systems in 115 countries around the globe. We are looking for the cream of the crop to join our team!
We offer competitive pay, exceptional career development, state-of-the-art facilities, and the opportunity to work with leaders in the field. But we also offer something more… the satisfaction that comes from knowing that the “product” we produce will improve the quality of human lives, and in some cases, save them. Our products, most importantly, are also accessible by people from all economic backgrounds.
We’d love to hear how you could contribute to the team!
The biopharmaceutical regulatory department is responsible for the management of regulatory activities pertaining to biopharmaceutical products. Specifically the compilation, preparation and submission of regulatory dossiers in the three key areas of interest, Canada, USA and Europe. Furthermore, the department provides technical/scientific advice, support and services to Quality Control, Research and Development, and Sales and Marketing. The department also interacts with relevant departments within Apotex and external partners such as Apotex Affiliates, Joint Venture partners and other international stakeholders to ensure that products are submitted, approved and launched in a timely manner.
Responsible for the preparation and compilation of dossiers for registration of Apotex biopharmaceutical products in the Europe, USA and Canada. This involves planning, managing, writing, and/or reviewing the activities and documents for the preparation of the required documentation. Strong links need to be established with all Apotex departments involved e.g. Medical and PV Department, IT, European headquarter, and specifically all external partners to ensure dossiers are compiled, submitted and approved in an efficient and timely manner.
* Plan and manage the activities to ensure compliance with internal and external standards and requirements.
* Advise on the content and format requirements for regulatory documents for biopharmaceutical products.
* Prepare clinical sections for clinical trial applications (CTA)/INDs/IMPDs or similar, and for market application dossiers, using the Common Technical Document (CTD) format for biopharmaceuticals, for the appropriate jurisdiction.
* Ensure that submissions are prepared and filed in compliance with the regulatory requirements for the relevant markets and within scheduled timeframes.
* Communicate with regulatory authorities via documentation/written communication on significant biopharmaceutical pre-clinical and clinical regulatory issues.
* Interact with external partners as necessary to ensure the appropriate information is obtained for submission.
* Interact with Sales and Marketing, Quality and Operations departments for the timely launch of biopharmaceutical products especially with respect to regulatory issues.
* Maintain regulatory compliance once market approval has been obtained.
* Keep abreast of changes in regulatory requirements of all jurisdictions.
* Establish and maintain professional standards of communication with colleagues within and outside of Apotex.
* Provide timely and appropriate reports to the Director, Regulatory Affairs, Biopharmaceuticals.
* Perform other duties as assigned by the Director, Regulatory Affairs.
* Accurately scopes out length and difficulty of tasks and projects and ensures timely management of projects and other deliverables.
* Post Graduate degree or equivalent in Biology, Biochemistry, Pharmacy or similar Life Sciences, preferably at doctorate level.
* Minimum five years experience in the biopharmaceutical industry with focus on clinical development (clinical phases I-III) of parenteral pharmaceutical human therapeutic products (Specific experience Biosimilars and Biologics development would be an asset) and clinical documentation.
* Proven expertise with medical writing & clinical study reports and investigator brochures for regulatory filing.
* Excellent problem-solving, planning, analytical, organizational, and written/verbal communication skills.
* Have detailed knowledge of the clinical compliance regulations and guidances from the U.S. FDA, EMEA and ICH.
* Excellent oral/written communication, leadership, organizational and interpersonal skills.
* PC proficiency with MS Word, Excel, PowerPoint, etc. Familiarity with IT systems, e.g. electronic submission systems like Docubridge.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.