Group Head, MRC (Maintenance Regulatory Centers)
- Hyderabad, India
1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.
Your responsibilities include, but are not limited to:
• Leads and manages a team of regulatory affairs managers/team lead(s) responsible for regulatory second wave submissions and maintenance activities for Sandoz Small Molecules to achieve regulatory and business objectives.
• Acts as a competent and strong business partner on maintenance/compliance matters within regulatory affairs and for NTO/ESO/QA.
• Builds strong interface with NTO/ESO/QA functions. Interacts with those functions to optimize processes to achieve regulatory and business targets.
• In cooperation with other regulatory functions, assesses and improves KPIs and metrics on second wave submissions/change evaluation/maintenance/variations/renewals.
• Supports NTO/ESO/QA on evaluation as well as execution of strategic projects. Provides best in class regulatory input to NTO/ESO/QA for decisions making.
• Ensures that oversight on maintenance (variations) is in place. Guides the regulatory organization to make sure that established processes and timelines for maintenance is followed.
• Ensures efficient working methods in accordance with the Guide to Good Regulatory Practice and internal guidelines as applicable.
• Leads, directs and motivates the team. Ensures proper training of the staff and development to maximize regulatory competence and strategic capabilities. Ensures that proper guidance and training for maintenance regulatory managers on regulatory requirements is in place.
What you'll bring to the role:
• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters or Ph.D.
• Excellent communication skills.
• Around 12 + Years Experience in Regulatory Life Cycle Management of Sterile Oncology Injectable products
• Around 5 years experience in people leadership
• Strong project management skills and negotiation skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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