Lead Executive - New Product Development & Regulatory Intelligence

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