• To generate high quality regulatory submissions to target markets throughout Europe in order to deliver a successful and timely portfolio of MA approvals in accordance with the company's requirements.
• Following MA approvals, maintenance of the MA approval activities including preparation and submission of variations and preparation for product launch.
• Successfully interact with the in-licensing partners and functional teams in India to ensure that data generated are appropriate and will be presented and compiled in accordance with EU requirements.

Responsibility

Results Expected/ Target

% of time spent

1

Successfully interact with the project and functional teams in India to ensure that data generated is appropriate and will be compiled and submitted in accordance with EU requirements.

Ensure all filings are happening on time

2

Provide support and guidance to the Global Regulatory Affairs EU team when evaluating new projects as part of the European Portfolio Meeting (EPM) process and Product Portfolio Meeting (PPM) process, by providing national regulatory insight and opinion on risks.

Ensure highlight of national requirements for new product applications

3

Direct communication with regulatory authorities to facilitate productive dialogue on all new and existing product submissions and other relevant issues.

.Ensure promptly and accurate communication with relevant national regulatory authorities

4

Timely generation and submission of regulatory applications (generally DCP, MRP,CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase for MA issue following closure of the European Regulatory Procedures.

Complete dossier submissions for projects in a timely manner.

3

Oversight of Regulatory Tracking Database. Liaise with contract services provider to ensure that the Regulatory Tracking Database is able to provide relevant and timely information on pending and approved products.

Ensure documentation are provided in timely manner

4

Post-approval activities including maintenance of approved Mas (variation, Renewal & PSURs) and launch activities.

Ensure all request from authorities are answered appropriately

5

Assistance in compilation of compliance files for new licence approvals and updating compliance files during life cycle of the product where necessary.

Ensure all necessary information applicable for WE markets is provided to EU GRA

6

Liaise with external companies with respect to in-licensing and out-licensing activities and any associated regulatory issues as required.

Generation of accordingly regulatory strategy

7

Perform dossier due diligence activities to advise on regulatory strategy to the business

Provide regulatory strategy, timelines and cost for an in-license project

External Interfaces

Internal Interfaces ( Other than Direct Reports)

• European Regulatory Affairs Agency
• Customers' and suppliers' regulatory departments
• CRO's
• Quality clinical and Non-clinical experts
• Document management eCTD
• Regulatory Consultants
• Senior Manager Regulatory Affairs & Pharmacovigilance and other members of EU Regulatory Team (Watford office)
• Business Development
• Project Management
• Regulatory Affairs - EU team in India
• Clinical scientists
• EU and US Formulation Development
• Analytical Departments
• companies and affiliates in Europe