Apotex Inc.,
Designation : Executive
Function : RA
Functional Area : Regulatory Affairs
Job Role Summary : Compilation and submission of dossiers, Maintain databases, Change control review, Support Global Project Management team for project planning and execution.
Job Profile :
- 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.
- 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.
- 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.
Job Requirements :
- Candidate should have minimum 7 years of experience in Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia market.
- 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).
Work / Job Experience : 7 Years
Type of Experience : Pharma regulatory experience in Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia market
Academic Qualifications :
- A Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar. Project Management would be additional advantage.
