Submission Manager - Mumbai, India
We currently have multiple openings in our Indian team for Regulatory Operations professionals with Publishing and artwork experience.
As part of G&L’s core team of Reg Ops professionals, the successful candidates will be working on a variety of global client projects for all regulated markets.
The Role
Working in a large, multinational team of Regulatory professionals, supporting a variety of Regulatory Operations activities including:
- Leading and driving global processes.
- Executing end-to end submission assembly which includes publishing, quality control verification, finalization and delivery across projects and programs.
- Assuming the role of lead publisher for larger, complex submissions (e.g. original marketing applications), which will include coordination of all publishing-related activities and delegation of activities to other publishers.
- Acting as a point of contact for Regulatory Affairs for transformation projects such as site/product divestments and long post-approval changes in Technical Operations.
- Providing project management capabilities to drive the execution and communication of transformation projects.
- Working closely with regulatory project managers to lead the production of high-quality submission assemblies utilizing submission-ready documents that adhere to internal and external electronic submission guidelines.
- Aligning action trackers and communications within NVS RA functions and providing oversight collaboration across the RA community by engaging with county organizations/affiliates.
- Evaluating activities and business processes, identifying areas in need of improvement and taking the lead in investigating potential solutions or new ways of working.
- Aligning with stakeholders regarding dossier updates in order to coordinate regulatory actions on the same brand and ensure proper project updates.
- Making timely updates to regulatory compliance systems, metadata and downstream.
Requirements
- A minimum of 5 years of experience in Regulatory Operations.
- Experience with supporting and leading complex publishing and submission projects and/or operating at the program level to ensure oversight of regulatory operations for transformation projects.
- Ability to work proactively with stakeholders and to communicate regulatory requirements and proposals.
- Must have experience in regulated markets, preferably with experience in emerging markets and international regions.
- Excellent communication skills – both written and spoken.
- Strong and proven project management abilities.
- Good working knowledge of regulatory operations systems, publishing tools, Adobe packages.
- A strong knowledge of the drug development process, regulatory operations, and other regulatory functions.
- The ability to work independently with minimal supervision and a quality approach to documentation and an eye for detail.
- This role requires strong IT skills, including working on a variety of client-specific operating systems.
- You will be expected to undertake regulatory tasks in Regulatory Operations and Submission Management projects independently.
- In addition to working to strict industry and client guidelines, you will be expected to use your initiative to continually develop your own knowledge and skills.
- You will be expected to support colleagues to achieve results.
How to Apply
For further details, please send your CV to: talentacquisition@gandlhealth.com
G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.