Senior Regulatory Affairs Specialist

Job Overview

• We are seeking a skilled Regulatory Affairs professional to join our team.

This is an exciting opportunity to work in a fast-paced environment and contribute to the success of our organization.

The ideal candidate will have experience in regulatory affairs, specifically in compilation and submission of new product registrations, as well as maintenance of documentation records.

The successful candidate will be responsible for supporting and/or coordinating regulatory affairs projects, preparing submission and approval notifications, and ensuring compliance with SOPs and regulatory guidelines.

Main Responsibilities:

• Compilation and submission of new product applications, deficiency responses, and pre-launch variations for assigned products;
• Maintenance of documentation/database records pertaining to products, in line with systems, processes, and procedures;
• SUPPORTING AND/OR COORDINATING REGULATORY AFFAIRS PROJECTS AS ASSIGNED;
• Preparation of submission and approval notifications for new product applications submitted to Regulatory agencies;

Supporting Responsibilities:

• Support in review and compilation of applications (i.e., ANDA, Co-dev applications, and ANDS) of drug products to Health authorities of US and Canada market;
• Support in review and compilation of deficiency packages for assigned products of US/Canada market within given timelines & with high quality measured against compiler checklist maintained by team;
• Review and compilation of New Product applications for international markets 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 (e.g. CBE, CBE-30, PAS, sANDS, and Level III) for assigned products;
• 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 Common Electronic Submission Gateway (ESG) for submission of applications for US & Canada market;
• In-depth review of all technical documents required for compilation of New Product Submission (NPD - ANDA/ANDS), Pre-launch variations, and query responses before sending it for final review;
• Completion of all 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, and pre-launch variation to meet agreed timeline;
• Provides regulatory support to stakeholders as and when required;
• Works in a safe manner collaborating as a team member to achieve all outcomes;
• Demonstrate behaviors that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion;
• 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.

Education:

A Postgraduate/Graduate in pharmacy.

Knowledge, Skills, and Abilities:

• Candidate should have knowledge about NPD submission requirement and compilation of dossier for US/Canada market.

Experience:

• Candidate should have minimum 3 years of experience in US/Canada market.

We value diversity and inclusion at our organization. We offer a welcoming and accessible work environment where everyone feels valued, respected, and supported to succeed.