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Job Description
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.