Senior Specialist Regulatory CMC

Job Description

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
• Ensure provision of high-quality CMC dossiers that meet companys 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 experienceEducation: 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).
Job Location:
• Electronic City Phase 1 - Bangalore
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!,

Keyskills :
active directorytroubleshootingenvironmentwindowsslaenvironmental impact assessmentlife cyclechange controlrisk assessmenttherapeutic areas