Responsibilities
Accountability.
Provide leadership and direction for the Submission Management sub-team within Submission Management.
Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.
Contributes to resource planning.
Acting as SME and solving the problems.
Supervises the day-to-day business of the Submission Management sub-team also direct support on routine submissions.
Can perform the work supervised, but typically focuses on the more complex/complicated topics and on managing the team.
Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
Responsible for day-to-day management, setting commitments, coaching and developing employees, performance appraisal, determination of reward outcomes.
Ensuring sustainability of knowledge, capability, and capacity required for the book of work, aligning with long-term organizational strategies.




Coordinating training initiatives, including onboarding of current hires, and coaching and mentoring team members.
Collaborating with the RQS Operations team to establish KPIs and ensure adherence to them, including communication to RQS Operations functions to support overall goals.

Qualifications
Work Experience: Around 14 years of qualified experience with Regulatory Publishing Submision Management
Key contact for eCTD and Publishing expertise.
Act as power-user for submission applications (RIM, eDMS, eSM).
Monitor compliance with submission standards and submission process (internal external).
Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Manager Regulatory Submission Management Bengaluru
🏢 Merck
📍 Bengaluru