Lead Executive - New Product Development and Regulatory Affairs

Lead Executive - New Product Development & Regulatory Intelligence

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

Job Summary

• Compilation and submission of new registration applications, deficiency responses and pre-launch variations for assigned products in international markets.
• Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures.
• Handling of change control review (CCR) related activities like confirmation on change assessment, document verification and closing of RA approval tracker.
• Supporting and/or coordinating regulatory affairs projects, as assigned.
• Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies.
• Should review applications to ensure one cycle approval.
• Support leaders are developing robust processes and systems to build high quality applications and reduce deficiencies from health agencies.
• Support Global Project Management team on activities related to project planning and execution.

Job Responsibilities

• Support in review and compilation of applications (i.e., new registration applications, deficiency responses and pre-launch variations) of drug products to international market.
• Support in review and compilation of deficiency packages for assigned products within given timeline & with high quality measured against compiler checklist maintained by team.
• Review and compilation of New Product applications for international markets for Solid oral, Co-development and injectable products, as assigned.
• Building dossier/applications into eCTD format and ensure documents meet strict internal and regulatory standards.
• Ensure dossier/documents are of high-quality standard to ensure one cycle review from Regulatory authorities.
• Support in review and compilation of supplements/pre-launch variations.
• Support in performing the initial due diligence before project selection for submission plan.
• Ensure to initiate project kick-off as per defined timeline to ensure alignment with key stakeholder on documents required for submission.
• Maintain records in global regulatory databases and in established trackers (Review checklist for NPD/deficiency response/ pre-launch variation, deficiency tracker, status sheet etc.) and ensure accuracy of information.
• Handling of submission portals like CESP for submission of for submission of applications for Europe market.
• Completion of all the assigned trainings in timely manner.
• Actively work to suggest, develop and obtain own Key Performance Measures (KPMs) in conjunction with Reporting Manager.
• Ensure compliance with SOPs and regulatory guidelines published from time to time by respective regulatory agencies.
• Act as a back-up for team members and support as and when required.
• Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
• Timely communication and follow-up with the respective departments for compilation and submission of new product submissions, query responses & pre-launch variation to meet agreed timeline.
• Provides regulatory support to stakeholders as & when required.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Courage, Teamwork, Innovation.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education:
  • A Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar. Project Management would be additional advantage.
• Knowledge, Skills and Abilities:
  • Demonstrated knowledge of the generic new product development process/requirements and compilation of dossier for key international markets such as Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia.
  • Must possess knowledge of the technical, quality compliance, and global regulatory requirements.
  • Excellent communication, presentation, and interpersonal skills.
  • Demonstrated experience in influencing & coordinating the complex regulatory activities and interaction with cross-functional teams & stakeholders.
  • Excellent understanding of Project Management principles and practice in a complex environment.
  • Excellent oral/written communication in English.
  • Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS-Excel, and MS-Project (or other PM software).
• Experience: Core Regulatory Affairs
  • Candidate should have minimum 7 years of experience in Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia market.

Exigences liées au poste

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer 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.

 

Experience Level

Senior Level