Location
Mumbai | India
Job description
About the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Job Purpose:
Provide and ensure timely preparation of high-quality CMC regulatory documentation and support in line with global regulatory submission plans and strategies.
Major Accountabilities
Life cycle management of Marketing Authorizations (MAs). Core experience in new submissions and life cycle management in major markets EU/US/CAN/JP/AUS/BR/CN will be an added advantage. New submissions in Most of World (MoW) regions and its planning as per targets
Responsible for MA transfers and maintaining product history as per defined timelines and processes. Author high-quality CMC documentation (dossiers) for health authority submission, with support and guidance, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
Organize high-quality CMC documentation (dossiers) for health authority submission, from license partners, applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
Experience of work sharing and super grouping variations submissions. Prepare CMC responses to health authority questions during development, registration and product lifecycle. Regulatory evaluation of change controls and various other quality events (e.g. Deviations, OOS/OOT/OOE etc.) for possible regulatory impact. Experience on managing administrative changes will be an added advantage.
Identify the required documentation for regulatory submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Experience of managing QP declarations, GMP certificates, CEPs, import permissions, COPP, legalizations, Apostille, translations, sample management as per global regulatory requirement
Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible. Keep knowledge up to date with regard to regulatory guidelines and requirements in all regions as well as for new technical trends.
Actively participate as a member of the global RegCMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. Establish and maintain sound working relationships with partners, stakeholders and customers.
Assume activities in support of the global databases and quality systems. Interactions with Health Authorities as and when required as per business requirements. Participation in special initiatives / projects of regulatory and manufacturing sites (as assigned by management). Regulatory project management
Role Requirements
Postgraduate in Pharmacy or Science (e.g. Analytical chemistry) or equivalent
Additional courses in Drug Product Regulatory Affairs would be added advantage.
Sr. Executive: Minimum7+ years of experience in core Reg CMC areas
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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