Merck KGaA

Senior Specialist - Regulatory Affairs Manager

Posted On

April 15, 2025

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

Full-time

Apply By

June 17, 2025

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.Ability to contribute to the dossier content and to perform content and quality review on regulatory documentationAbility to develop and prepare successful regulatory strategies and dossiers.Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request.Ability to execute appropriate risk assessment and mitigation in cooperation with line manager /team leadAbility to provide Regulatory expertise into the planning and execution of projects and tasksAbility to work within a matrix organisation, build relationships with internal or external stakeholder Who You Are:8-12 years of work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. 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)Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variationsExperience 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 requirementsIn 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 strategiesStrong project management and documentation skills, proactive communication approachContributor level experience with RIM and EDMS RA applications.

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