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Senior Specialist Regulatory CMC
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.
- 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
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).
- 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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
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