Require Regulatory Project Manager at Merck

Job Title: Regulatory Project Manager
Location: Bangalore, Karnataka | Industry: Pharma/Healthcare/Clinical Research

About Merck

At the core of our mission is a passion for science and technology that drives our 63,000 employees across 65 countries. We strive to find solutions to today’s most challenging problems and create sustainable ways of living. Our work spans every step of life—helping people create, improve, and prolong life. From personalized treatments for serious diseases to enabling people to achieve their dream of parenthood, we are dedicated to supporting individuals and empowering the scientific community.

We provide tools, services, and digital platforms to simplify and accelerate research, ensuring accurate tests and trusted medicines. As a pioneer in digital innovation, we are revolutionizing how data is accessed, stored, and processed, transforming life on Earth as we know it.

Position Overview: Regulatory Project Manager
As a Regulatory Project Manager, you will be responsible for planning, coordinating, and tracking global regulatory submissions for complex pharmaceutical products. You will work in a collaborative matrix organization, ensuring efficient communication and resource allocation for the success of regulatory submissions across multiple regions. Your role will require expertise in managing life cycle maintenance activities and operational tasks to support the business’s regulatory priorities.

Key Responsibilities:

• Develop project plans for global regulatory submissions, including CTA/IND, MAA/NDA/BLA, and HA meetings.
• Collaborate with the Global Regulatory Lead and Submission Manager to ensure smooth execution of submission strategies.
• Oversee submission handovers and ensure all relevant information is provided to GRA Operations for efficient submission planning.
• Manage risks and maintain risk registers in collaboration with the Global Regulatory Affairs team.
• Lead the Submission Taskforce, driving coordination and managing interdependencies to address risks and issues.
• Oversee day-to-day operations and ensure hyper care for critical submissions to Health Authorities.
• Manage budgets and collaborate with Global Project Management and Project Controllers to track costs and ensure compliance.
• Assist with regulatory resource and budget planning for global rollout and due diligence projects.
• Provide post-approval regulatory expertise, maintaining a thorough understanding of global regulatory requirements for life cycle management.
• Improve project management tools and ensure compliance with Health Authority standards.

Candidate Profile

• Education: Minimum MSc or equivalent degree in Life Sciences, Medical, PharmD, or a related field. A PhD or advanced training in project management is highly desirable.
• Experience: 8-14 years of work experience in a pharmaceutical environment, with 6-8 years in regulatory affairs or as a regulatory project manager. Experience in academia, R&D, or competent authorities will be an advantage.
• Skills:
  • Strong knowledge of EU and international regulatory requirements.
  • Experience with RIM and EDMS RA applications.
  • Excellent communication skills and a collaborative mindset.
  • Ability to manage complex projects and work with diverse teams.
  • Strong customer orientation and a results-driven approach.

Additional Information

• Experience: Minimum 5+ years
• Location: Bangalore, Karnataka
• Industry: Pharma/Healthcare/Clinical Research
• End Date: 25th October 2024

Join us to contribute to groundbreaking scientific advancements and help transform life on Earth.

This post highlights the role and emphasizes the company’s mission, blending the need for advanced scientific expertise with collaboration and innovation.