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 current 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

📌 Regulatory Officer - CMC & EU || Pharma || Ahmedabad
🏢 Adecco India
📍 Ahmedabad