Merck KGaA

Senior Specialist Regulatory CMC

Posted On

June 14, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

July 2, 2024

Job Description

Title: Senior Specialist – Regulatory CMCLocation: Bangalore – Electronic City Job Role:Ensure provision of high-quality CMC dossiers that meet company's and health authorities’ requirements.Enable representatives from all major disciplines involved to reach agreement on the CMC dossier and strategy.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. Who You Are:9-10 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 5 years of Global CMC regulatory experience. Education: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) Job Specific Competencies & Skills:Act as product expert for mature products.Conduct change control regulatory assessment for multiproduct site changes, incl., updating the CCP tracker, and performing required notifications Management and responsibility of assigned CMC Regulatory activities and projects.Examples for these comprise answers to Health Authority queries, life cycle management submissions, marketing authorization applications.Accountable and responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions.This includes assessment of Change Control Proposals for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.Accountable and responsible for global CMC-part of the regulatory strategy (RSD and DSP). This encompasses risk assessment, strategic support and advice.Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan.Accountable and responsible to confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team). We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, color, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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