Location: Bangalore, Karnataka
Industry: Pharma/Healthcare/Clinical Research
End Date for Applications: 25th October 2024
About Us
At Merck, our passion for science and technology drives our 63,000 employees across 65 countries to tackle some of today’s toughest challenges and create sustainable solutions. We’re dedicated to improving lives—delivering personalized treatments, supporting families, and empowering the scientific community. Join us to help make breakthroughs happen.
Position Overview
We are seeking a Regulatory Project Manager to lead global regulatory planning and manage the delivery of complex submissions to health authorities. This role is vital in ensuring that our products meet regulatory standards and are successfully brought to market.
Key Responsibilities
- Develop comprehensive project plans for regulatory submissions (e.g., CTA/IND, MAA/NDA/BLA).
- Collaborate with the Global Regulatory Lead and Submission Manager to strategize and execute submissions.
- Facilitate smooth handover of submissions to GRA Operations, ensuring all necessary information is provided.
- Manage the execution of submissions, addressing any issues that could impact timelines.
- Maintain risk registers and oversee regulatory activities across functional areas.
- Lead the Submission Taskforce, ensuring all deliverables are aligned and risks are addressed.
- Consolidate budget demands and track expenses for GRA&RDQ, acting as a key liaison for project management.
- Assess global regulatory resource needs for various projects.
- Improve project management tools and templates, ensuring compliance with health authority requirements.
- Foster strong collaborations with project controllers and global project management teams.
Candidate Profile
- Education: Degree in Life Science, Medical, PharmD, or related discipline (minimum MSc; PhD preferred).
- Experience: 8–14 years in a pharmaceutical setting, with at least 6-8 years in regulatory affairs or project management.
- Strong knowledge of global regulatory requirements and lifecycle management for pharmaceutical products.
- Proficient in regulatory information management (RIM) and electronic document management systems (EDMS).
- Excellent written and verbal communication skills in English.
- Ability to work collaboratively and positively influence team dynamics.
- Strong customer orientation and results-driven mindset.
Why Join Us?
At Merck, you’ll be part of a mission-driven team committed to innovation and excellence. You’ll work in a dynamic environment that encourages professional growth and offers the chance to make a significant impact in the healthcare field.
Apply Now!
To join our team and contribute to life-changing projects, please submit your application by 25th October 2024.
