Executive - New Product Development

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