Merck Limited Hiring Regulatory Submission Management Senior Manager

Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd.

Post : Senior Manager - Regulatory Submission Management

Job Description
• 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 new 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.

Job Specific Competencies
• 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

Candidate Profile
Around 14 years of professional experience with Regulatory Publishing & Submision Management

Additional Information
Experience : 14 years
Location : Bangalore, Karnataka, India
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : 302780
End Date : 30th September 2026