Merck KGaA
Senior Specialist - Regulatory CMC
Job Description
Title: Senior Specialist – Regulatory CMCLocation: Bangalore – Electronic City Job Specific Competencies & Skills:Ability to understand and support the development of regulatory CMC strategies and CMC dossiers i.e. Module 3, Module 2Comprehensive knowledge and Experience with developing regulatory CMC strategies and CMC dossier content requirements i.e. Module 3, Module 2.Experience in preparation and management of regulatory CMC documentation, including preferably international new product applications or variations. Experience with regulatory CMC life-cycle management activities would be an asset.Practical experience in one of the following area synthetic molecules and/or biotech molecules: manufacturing process development, transfers, validation or analytical development and quality managementAwareness of global pharmaceutical legislation specifically linked to regulatory CMC aspects in the ICH countries.Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German).Good interpersonal skills and flexible mindset.Attention to details.Ability to work in multinational teams.Awareness of Project managementAwareness of regulatory CMC affairs contribution to Pharma business. 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.
Jobs at Bangalore
Capgemini
Cost Accounting with SAP S/4HANA Co…
Experienced Professionals
Bangalore, Karnataka
Last Date: Feb. 5, 2025
Infosys
Observability Architect
5 - 15 Years Exp.
Bangalore, Karnataka
Last Date: March 31, 2025
Amazon
Software Development Engineer, Amaz…
Freshers/Experienced
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Virtusa
Azure Devops Architect
Full Time
Bangalore, Karnataka
Last Date: Sept. 30, 2025
Merck KGaA
Head of Sales Enablement & Customer…
E - Professional (10+ years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Razorpay
Senior Associate - New Initiatives …
Freshers/Experienced
Bangalore, Karnataka
Last Date: Jan. 25, 2025
Amazon
Sr Tech PM BizOps Strategy (SAnDS),…
Freshers/Experienced
Bangalore, Karnataka
Last Date: Jan. 28, 2025
More Jobs at Merck KGaA
Merck KGaA
Specialist - Quality Services
C - Professional (1-3 years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Merck KGaA
Business Executive
C - Professional (1-3 years)
Mumbai, Maharashtra
Last Date: Jan. 28, 2025
Merck KGaA
Low Code App Dev Manager
E - Professional (10+ years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Merck KGaA
Business Executive
C - Professional (1-3 years)
Mumbai, Maharashtra
Last Date: Feb. 4, 2025
Merck KGaA
Validation Engineer
C - Professional (1-3 years)
Bangalore, Karnataka
Last Date: Feb. 4, 2025
Merck KGaA
Front End Engineering Manager
D - Professional (4-9 years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Merck KGaA
SAP BTP Integration Architect
E - Professional (10+ years)
Bangalore, Karnataka
Last Date: Feb. 4, 2025
Merck KGaA
Business Executive
C - Professional (1-3 years)
Mumbai, Maharashtra
Last Date: Jan. 28, 2025
Merck KGaA
Life Science- Process Solutions Mar…
C - Professional (1-3 years)
Bangalore, Karnataka
Last Date: Feb. 4, 2025
Merck KGaA
Senior Analyst
D - Professional (4-9 years)
Bangalore, Karnataka
Last Date: Feb. 4, 2025
Merck KGaA
Business Analyst
C - Professional (1-3 years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Merck KGaA
Senior Analyst
D - Professional (4-9 years)
Bangalore, Karnataka
Last Date: Jan. 28, 2025
Actively Recruiting Companies at Bangalore, Karnataka