Work as Regulatory Affairs Manager at Merck

Our passion for science and technology is what drives our around 63,000 employees in 65 countries to find solutions to some of today’s toughest challenges and create more sustainable ways to live. We are here for people at every step, helping to create, improve and prolong life. We deliver personalized treatments for serious diseases and enable people to achieve their dream of becoming parents. We empower the scientific community. Our tools, services and digital platform make research simpler, more exact, and help deliver breakthroughs more quickly. Our solutions accelerate access to health by assuring tests are accurate and the medicine we take can be trusted. We are the company behind the companies, advancing digital living. Our science sits inside technologies that are changing the way we access, store, process, and display information.

Post : Senior Specialist - Regulatory Affairs Manager

Job Description
The Senior Specialist/ Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.

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 have to work on complex tasks and to propose solutions and strategies as part of their day to day work.

Job Specific Competencies & Skills :
• Ability to contribute to the dossier content and to perform content and quality review on regulatory documentation
• Ability to develop and prepare successful regulatory strategies and dossiers
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
• Solid experience in Regulatory Affairs regulatory dossiers and regulatory procedures on a global scale, including submission/registrations types and related requirements
• In Depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (CP, MRP, DCP, National etc.) and LCM strategies
• Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
• Strong project management and documentation skills, proactive communication approach
• Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team lead
• Ability to provide Regulatory expertise into the planning and execution of projects and tasks
• Ability to work within a matrix organisation, build relationships with internal or external stakeholder
• Contributor level experience with RIM and EDMS RA applications
• Excellent written and spoken communication skills and English language knowledge

Candidate Profile
• Degree in a Life Science, Medical, PharmD or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
• 8-12 years of work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role.

Additional Information
Experience : 8-12 years
Qualification : Degree in a Life Science, Medical, PharmD
Industry Type : Pharma/ Healthcare/ Clinical research
Location : Bangalore, Karnataka
End Date : 30th April 2025