Manager – Submission Management
Location: Bangalore, Karnataka, India
Job ID: 303367
Department: Global Regulatory Affairs
Function: Regulatory Submission Management
Position Overview
Merck is seeking an experienced Manager – Submission Management to lead and develop the Submission Management sub-team within Global Regulatory Affairs.
The role is responsible for ensuring regulatory submissions are delivered with the highest standards of quality, compliance, and timeliness. The successful candidate will provide operational leadership, technical expertise, and people management while driving continuous improvement across regulatory submission processes.
As the subject matter expert for electronic Common Technical Document (eCTD) and submission management, the Manager will support the team in addressing complex regulatory challenges, harmonizing submission activities, and maintaining compliance with global regulatory requirements.
Key Responsibilities
Team Leadership and Management
Lead the Submission Management sub-team within Global Regulatory Affairs.
Manage the team's day-to-day activities, priorities, workload, and performance.
Set clear objectives and ensure timely and high-quality delivery of regulatory submissions.
Coach, mentor, and develop team members to strengthen technical and professional capabilities.
Conduct performance management and support talent development initiatives.
Foster an inclusive, collaborative, and engaging team environment.
Support onboarding and capability-building activities for new and existing team members.
Ensure long-term sustainability of team knowledge, expertise, and capacity.
Regulatory Submission Management
Oversee regulatory submission activities to ensure quality, compliance, and timely delivery.
Provide subject-matter expertise in electronic Common Technical Document (eCTD) standards and submission processes.
Guide the team through complex submission requirements and regulatory challenges.
Ensure submission activities comply with Health Authority requirements and established standard operating procedures.
Monitor submission quality and identify opportunities for improvement.
Harmonize submission activities across different functional areas and stakeholders.
Support efficient and consistent execution of global regulatory submissions.
Process Improvement and Compliance
Monitor compliance with regulatory submission standards and internal procedures.
Establish and monitor key performance indicators (KPIs) related to submission management.
Identify process gaps and implement continuous improvement initiatives.
Drive improvements in submission quality, efficiency, consistency, and overall operational performance.
Promote the effective use of submission management tools and technologies.
Contribute to the standardization and optimization of regulatory submission processes.
Systems and Technology
Provide expertise in eCTD standards and electronic submission processes.
Work with regulatory information management platforms and electronic document management systems.
Utilize electronic submission management tools to support regulatory workflows.
Promote effective use of technology to improve submission quality and operational efficiency.
Maintain awareness of developments and best practices in regulatory submission technology.
Cross-Functional Collaboration
Collaborate with stakeholders across Regulatory Affairs and other functional areas.
Serve as a key point of contact for submission management expertise.
Build and maintain effective relationships with stakeholders across different functions, regions, and geographies.
Operate effectively within a global matrix organization.
Align submission management activities with broader organizational and regulatory strategies.
Facilitate clear communication and coordination across teams.
Required Qualifications and Experience
9–11 years of professional experience in regulatory publishing and submission management within the pharmaceutical industry.
At least 2 years of experience in a team leadership or supervisory role.
Bachelor's degree or equivalent qualification in Pharmacy, Life Sciences, or a related scientific discipline.
Deep expertise in eCTD standards and regulatory submission processes.
Strong understanding of global regulatory submission requirements.
Proven experience working with regulatory information management platforms.
Experience with electronic document management systems used in regulatory submission workflows.
Strong understanding of Health Authority requirements and regulatory compliance.
Experience monitoring and improving compliance with submission standards and SOPs.
Familiarity with electronic submission management tools.
Leadership Competencies
Strong people management and leadership skills.
Proven ability to coach and mentor team members.
Strong performance management capabilities.
Ability to develop talent and build team capabilities.
Excellent stakeholder management skills.
Ability to work effectively in a matrix and globally distributed environment.
Strong communication and interpersonal skills.
Ability to manage competing priorities and deliver results within strict timelines.
Commitment to continuous improvement and operational excellence.
Ideal Candidate Profile
The ideal candidate is an experienced regulatory publishing and submission management professional with strong expertise in eCTD and electronic regulatory submissions.
The candidate should combine technical regulatory knowledge with strong people leadership, stakeholder management, and process improvement capabilities. The ability to guide teams through complex submission activities while maintaining high standards of quality, compliance, and efficiency is essential.
About the Healthcare Organization
Merck's Healthcare organization focuses on helping create, improve, and prolong lives through medicines, intelligent devices, and innovative healthcare technologies.
The organization operates globally across therapeutic areas including Oncology, Neurology, and Fertility. Teams collaborate across multiple regions and functions to advance healthcare innovation and improve patient outcomes.
Work Culture and Development
Merck promotes an inclusive and flexible working environment that values diverse perspectives, collaboration, innovation, and continuous learning.
Employees are encouraged to develop their skills, take ownership of their work, contribute ideas, and pursue opportunities for professional growth and career advancement.
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Remote, India | Siliguri |Illinois :
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