Specialist – Regulatory Business Transformation
Company: Merck KGaA
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: Regulatory Affairs / Life Science Business
Job Overview
Merck KGaA is seeking a Specialist – Regulatory Business Transformation to support global regulatory operations and product launch activities within its Life Science business. This role focuses on regulatory data management, compliance assessment, and cross-functional coordination to ensure products meet global regulatory requirements and are successfully introduced into international markets.
The position involves collaboration with product management, project teams, and global stakeholders to manage regulatory data, ensure compliance with international standards, and support regulatory decision-making processes. The ideal candidate will have strong regulatory knowledge, project management expertise, and experience working with product data and compliance frameworks in regulated environments.
Key Responsibilities
Collaborate with internal Product Management and Project Management teams to support timely product launches across global markets.
Ensure compliance with global regulatory frameworks including Globally Harmonized System (GHS), Safety Data Sheets (SDS), chemical registration, and trade compliance requirements.
Work with global business teams to collect detailed product composition data, physical properties, and other relevant regulatory information required for regulatory assessment.
Analyze product formulation data and support regulatory decision-making related to product marketability and hazardous classification.
Prepare and manage regulatory data using Microsoft Office tools, SAP modules, and big data platforms for downstream processing.
Coordinate with regulatory teams to consolidate regulatory assessments, documentation, and compliance requirements.
Support documentation processes related to product safety and regulatory characterization.
Partner with internal processing teams to ensure accurate handling of regulatory information and compliance data.
Manage assigned projects independently and apply project management methodologies to ensure successful execution.
Drive continuous improvement in regulatory data management and transformation processes.
Education Requirements
Master’s degree in Natural Sciences or related scientific discipline.
Experience Required
Minimum 3+ years of experience in regulatory data management, regulatory compliance, or product stewardship within life sciences, chemicals, or regulated industries.
Experience working with global regulatory laws and frameworks, including GHS, SDS, and chemical compliance regulations preferred.
Demonstrated experience in project management and regulatory operations.
Familiarity with product composition and chemical data management is required.
Experience using enterprise systems such as SAP EHSM, JIRA, Palantir, or similar platforms is desirable.
Basic knowledge of data analytics and regulatory data processing tools preferred.
Core Skills and Competencies
Strong understanding of regulatory requirements and product compliance frameworks.
Knowledge of product data management, chemical composition analysis, and safety documentation processes.
Proficiency in Microsoft Office Suite and enterprise regulatory systems.
Strong project management and organizational capabilities.
Effective communication and stakeholder management skills.
Analytical thinking with strong problem-solving abilities and critical reasoning.
Result-oriented approach with the ability to influence stakeholders without direct authority.
Collaborative mindset and ability to work effectively within global cross-functional teams.
Work Environment and Career Development
This role offers the opportunity to work in a global regulatory environment supporting innovative life science solutions. The organization provides a collaborative and inclusive workplace with opportunities for professional growth, international exposure, and career advancement.
Diversity and Equal Opportunity
The organization is committed to equal employment opportunities and maintains a workplace free from discrimination based on race, gender, religion, age, disability, sexual orientation, or other protected characteristics.
About the Organization
Merck KGaA is a global science and technology company operating across healthcare, life sciences, and electronics sectors. The organization focuses on advancing innovation through scientific research and digital transformation to improve lives worldwide.
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