Senior Specialist – Regulatory Project Management
Company: Merck KGaA
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Global Regulatory Affairs
Job Overview
Merck KGaA is seeking a Senior Specialist – Regulatory Project Management to lead global regulatory planning and execution activities for complex regulatory submissions and product lifecycle management. This role focuses on strategic regulatory project coordination, submission planning, risk management, and cross-functional collaboration to ensure timely and compliant submissions to global health authorities.
The position operates within a matrix organizational structure, requiring strong stakeholder engagement, operational leadership, and regulatory expertise to support global regulatory strategies, submission activities, and lifecycle management of pharmaceutical products.
Key Responsibilities
Lead global regulatory planning and tracking of regulatory deliverables for moderate to highly complex submissions to health authorities worldwide.
Develop and manage project plans for major regulatory submissions including CTA, IND, MAA, NDA, BLA, and health authority meetings.
Collaborate with Global Regulatory Leads and Regulatory Affairs Managers to implement submission strategies and coordinate with Submission Managers for execution.
Oversee the handover of planned submissions to Global Regulatory Affairs Operations to ensure smooth implementation and execution.
Coordinate and manage submission activities to global health authorities, ensuring adherence to timelines and compliance requirements.
Lead submission task forces, manage deliverable dependencies, and address risks impacting submission timelines.
Implement crisis management strategies and resolve project issues affecting regulatory milestones.
Establish and maintain risk registers and manage regulatory risks using enterprise systems.
Drive cross-functional coordination and harmonize regulatory activities across business units.
Support lifecycle management activities for pharmaceutical products, including post-approval changes and regulatory updates.
Ensure preparation and maintenance of regulatory documentation required for global product registration and lifecycle management.
Manage regulatory project budgets, track financial planning, and coordinate cost tracking with project controllers.
Support due diligence activities, licensing projects, and asset transfers by coordinating operational regulatory processes.
Develop and improve project management tools, templates, and processes aligned with global regulatory requirements.
Collaborate closely with global project management teams, regulatory operations, and external stakeholders.
Education Requirements
Master’s degree or equivalent qualification in Life Sciences, Pharmacy, Medicine, or a related scientific discipline.
Higher academic qualifications such as PhD or advanced certifications in project or portfolio management are preferred.
Experience Required
8–14 years of professional experience in the pharmaceutical industry, regulatory authority environment, or academic research related to regulatory affairs.
Minimum 6–8 years of direct experience in regulatory affairs or regulatory project management.
Strong experience in global regulatory submissions, lifecycle management, and regulatory compliance processes.
Experience working with Regulatory Information Management (RIM) and Electronic Document Management Systems (EDMS) preferred.
Knowledge of EU and international regulatory frameworks and health authority requirements for pharmaceutical product registration.
Technical Knowledge and Competencies
Strong understanding of global regulatory procedures, submission strategies, and regulatory dossier management.
Knowledge of regulatory documentation requirements such as CPPs, GMP certificates, marketing licenses, attestations, and related legal frameworks.
Familiarity with post-approval changes, regulatory lifecycle management, and international regulatory guidelines.
Strong project management, risk management, and operational planning capabilities.
Excellent written and verbal communication skills in English.
Ability to work effectively within cross-functional global teams and influence stakeholders.
Strong organizational skills with high attention to quality and strategic outcomes.
Customer-focused mindset with strong ownership and accountability.
Financial and Operational Responsibilities
Support regulatory budget planning, cost tracking, and financial reporting activities.
Assist in quarterly cost planning exercises and monitor actual spending against regulatory project budgets.
Coordinate purchase orders and financial processes related to regulatory project activities.
Work Environment and Career Growth
This role provides an opportunity to contribute to global regulatory strategy and innovation within a dynamic healthcare and life sciences environment. The organization offers a collaborative workplace, international exposure, and strong career development opportunities in regulatory leadership and global project management.
Diversity and Equal Opportunity
The organization is committed to maintaining an inclusive and diverse workplace and provides equal employment opportunities without discrimination based on legally protected characteristics.
About the Organization
Merck KGaA is a global leader in science and technology, operating across healthcare, life sciences, and electronics. The organization focuses on advancing research-driven innovation to improve patient outcomes and enable scientific progress worldwide.
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