Executive, Regulatory Affairs NPD US & Can

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

• •Preparation of new submissions and deficiency responses to Regulatory agencies (US and Canada) for Injectables (Sterile Dosage Forms)
• •Review of quality documents required for regulatory NPD submissions and deficiency responses.
• •Maintenance of documentation/database records pertaining to approved products in line with systems, processes and procedures.
• •Leading and/or coordinating regulatory affairs projects, as assigned.

Job Responsibilities

• •Responsible for the preparation and review of quality regulatory NPD submissions for various markets (US and Canada) to ensure timely approval for Injectables (Sterile Dosage Forms).
• •Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada).
• •Responsible for review of quality/regulatory documents for new submissions and deficiency responses.
• •Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.
• •Works with other functional areas to resolve issues related to information for regulatory submissions.
• •Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).
• •Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information.
• •Co-ordinate with third party manufacturers for document requirement for regulatory submissions.
• •Act as a back-up for team members and support as & when required.
• •Timely communication and follow-up with the respective departments for compilation and filing of submissions and query responses to meet agreed timeline.
• •Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).
• •Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems.
• •Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.
• •Works in a safe manner collaborating as a team member to achieve all outcomes.
• •Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage and 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.

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 Injectables (sterile) for key markets such as US, Canada and EU.
• •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 4-7 years of experience in US, Canada and/or EU

At Apotex, we are committed to fostering a welcoming andaccessible 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.