Senior Manager, Regulatory Affairs Job in Mumbai at Genpact

Responsibilities of the Candidate:

• Set-up and onboarding (training according to SOP and establishment of partnership KPIs) 
• Development of regulatory strategy for each product (Gap analysis, positioning and classification of variations, timelines associated accordingly). 
• Work cross-functionally with Pharmanovia’s PV and Artwork department for planning.
• Plan the submissions at local level within the agreed timeframe
• The follow up of health authority review and assessment of the variations by liaising with locals up to the approvals 
• Preparation of response to questions. 
• Full life-cycle management, regulatory intelligence, proposed planning, and partnership with client local consultancies to achieve the objectives laid out
• Support in the EU at country level can be included as optional. 
• Full life-cycle management to include: 
• Generate compliant submission documents
• Regulatory tracking and update of RIMS 
• Dossier control and versioning o eCTD/Nees publishing 
• Artwork review and approval for submissions and final implementation upon approval of the safety variation.
• Leverage subject matter knowledge on business / project implementation issues related to the Regulatory process.
• Recruit new team members. Mentor for their growth.
• Through active management of status and expected deliverables, identifies risks, and formulates a strategy to mitigate those risks to quality and timeliness of submissions.
• Manages and leads a team of Reg Affairs professionals to deliver quality, first time right, regulatory content.
• Project manages a team to ensure deliverables and service levels are met and within the agreed timelines.
• Maintains a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and translation requirements as required.
• Assists with interpretation of regulatory technical guidelines in order to produce business requirements and ensure that those requirements are implemented where appropriate at the local level.
• Adheres to the required use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Works with the client to develop a clear and detailed plan for reporting metrics.
• Acts as the liaison/single point of contact to the client for all process-related items and participates in client governance meetings on a regular basis.