Regulatory Affairs Associate I
Navi Mumbai, India, 400706
Who we are
The opportunity
- To support the UK/IE Regulatory Affairs Team with full administrative support in order to ensure full lifecycle management of Marketing Authorisations (MA’s), tracking tools, systems and databases are kept up to date.
- Assist with all aspects of administrative management and equipment/software inventories as required
How you’ll spend your day
- To work closely with the Line Manager to ensure completion of tasks within agreed timelines
- Monitor team inboxes where required
- Administrative support and preparation and management of Product Information in the Teva Document Management System
- To generate and submit simple variations/label leaflet updates for approved UK/IE products licences.
- Provision of UK/IE specific information and/or documentation to EU Regulatory Affairs in support of new marketing authorisation applications and variation submissions
- Ensure that electronic files are up to date and maintained in accordance with Teva procedures
- Identify and escalate areas of administrative process improvement
- Accurately updating regulatory information systems following updates
- Provide support to the UK/IE RA team for all projects which include specific documentation requests
- Proof reading of mock-ups ensuring compliance at all times
- Providing ad hoc support to requests from various department functions
- Administrative support for the cancellation process in accordance to internal processes
Major Job Challenge(s):
- Meeting specific objectives whilst addressing frequent and often unscheduled issues and changing priorities
- To regularly discuss administrative workload and ideas for improving processes within the department and to request/offer assistance where needed
- Working with a wide range of internal and external customers
Your experience and qualifications
Qualification: M. Pharma
Experience: 2 – 4 Years of experience in relevant pharmaceutical field.
Knowledge:
- Basic understanding of processes and departments within a pharmaceutical company
- Microsoft Word, Excel and Outlook
Skills
- Excellent oral and written communication
- Ability to work under pressure and to tight time deadlines
- Effective time and organisation management
- Being able to work under your own Initiative and as part of a team.
- Computer literacy
Relationships
Internal:
- All personnel within UK/IE Regulatory Affairs
- EU Regulatory Affairs
- Manufacturing, QC testing and QA release sites
- Supply Chain and EDP
- Medical Affairs, Medical Information and Pharmacovigilance
- Commercial, Portfolio and Marketing
- Artwork Generation Groups
- Regulatory Information Management Team
External:
- Business Partners
- Customers
- Suppliers
- MHRA
- HPRA
Reports To
Associate Director, Senior Manager or Manager Regulatory Affairs
Teva’s Equal Employment Opportunity Commitment