Regulatory Officer - CMC & EU || Pharma || Ahmedabad

Role & responsibilities

• Life-science graduate with minimum of 2-4 years of Regulatory affairs experience in Lifecycle management preferred with exposure and knowledge of variation preparations and filings, CPP applications etc..
• Knowledge of CMC (Chemistry, Manufacturing, and Controls) and EU regulations, being able to ensure consistency and efficiency as well as monitor and maintain priorities.

Administratively well-organized, have attention to detail, possess strong written and oral communication skills and be able to manage multiple priorities.

Preferred candidate profile

• Compile and maintain Marketing Authorisation (e.g. CMC variations, renewals, PIQ, 61(3), BSVs substantial amendments) in collaboration with Regional Regulatory team
• Coordinate, collection, due diligence of functional documents and / or create country specific documents for regulatory applications
• Preparation of documentation/responses/notifications for National procedures
• Obtaining MAA Renewals/Notifications
• Correspondence with regulatory authorities & other relevant agencies
• Maintaining files for product licenses
• Ensure the maintenance of regulatory databases and departmental filing systems to facilitate accurate and retrievable records of department activities.
• Regulatory support for registration of drug product in new territories (including MENA, CIS, other ROW markets)
• Obtaining, tracking certificates of pharmaceutical products from UK/NL/IE for MENA/CIS, ROW countries
• Monitoring and filing of safety variations for PV compliance purposes
• Broad experience of managing relevant regulatory submissions, with demonstrated ability to work independently and manage complex projects.
• Ensure compliance via timely submissions to regulatory agencies
• Monitor submission and follow-up with local authorities in a timely manner for registration activities.
• Ability to handle multiple tasks/projects and manage priorities accordingly.
• Able to work under pressure and to strict deadlines
• Good written communication skills with attention to detail.
• Provide local support to the EU Regulatory department when necessary in case of specific contact to take with the local authority or review of national requirements;
• Development of artworks liaising with artists/designers
• Follow artwork implementation

Interactions with and support to stakeholders:

• Develop professional and effective working relationships with national regulatory agencies.
• Develop professional and effective working relationships with internal and external stakeholders.
• Be a proactive and collaborative partner to other functions, eg, marketing/sales within local commercial business, supply chain and quality to deliver company objectives.
• Contribute to launch readiness, other commercial project team, if needed