Manager - Submission Management

Merck; Bengaluru; Presencial; INR 1.800.000 - 2.400.000; Jornada completa

Descripción de la vacante

Merck in Bengaluru, India seeks an experienced leader to oversee the Submission Management sub-team within Regulatory Affairs. You will supervise day-to-day activities, drive performance, ensure timeliness, quality, and alignment with Health Authority requirements.

The role emphasizes coaching, KPI alignment with RQS Operations, and involvement in training and knowledge continuity, with focus on complex topics and cross-functional matrix collaboration.

Formación

• Experience in Regulatory Publishing/Submission Management.
• 9–11 years of professional experience in regulatory submissions.
• Ability to guide complex topics and manage a team.

Responsabilidades

• Lead and supervise the Submission Management sub-team.
• Coordinate scheduling, progress, and quality of submissions.
• Coach and develop team members and conduct performance appraisals.
• Ensure compliance with health authority requirements and internal SOPs.
• Collaborate with cross-functional stakeholders to achieve KPIs.

Conocimientos

eCTD & Publishing

RIM/eDMS/eSM power-user

Compliance monitoring

Quality & templates

Educación

B.Pharm, M.Pharm, MBA or Post graduate in Science

Herramientas

RIM

eDMS

eSM

Descripción del empleo

Job Summary

Accountability/Interdependence. Provide leadership and direction for the Submission Management sub-team within Submission Management.

Responsibilities

• Accountable for performance and results of Submission Management sub-team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.
• Supervises the day-to-day business of the Submission Management sub-team.
• 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.
• Acts within clear guidelines and receives guidance and oversight from manager to set team goals and priorities.
• 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.
• Impact. Ensuring compliance with Health Authority requirements, functional SOPs, and other internal guidance to support the overall strategic objectives of the organization.
• Streamlining submission processing by guiding and harmonizing activities across functional areas to optimize regulatory operations in line with strategic goals.
• Complexity. Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs.
• The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced Publishing Submission Management professionals.
• Scope of people responsibility. Resource planning, hiring, performance management.
• Coordinate training and people development, compensation and benefits.
• Ensuring a positive and inclusive workplace culture applying diversity and inclusion.
• Cultivate employee engagement and well-being.

Education

• B.Pharm, M.Pharm, MBA or Post graduate in Science.

Work Experience

• 9 - 11 years of professional experience with Regulatory Publishing/Submission Management.

Job Specific Competencies / Skills

• 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.