Group Head, MRC (Maintenance Regulatory Center)

Job Description

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:Your responsibilities include but not are limited to: Provide a robust framework to coordinate the management, compilation and timely dispatch of high quality, regulatory compliant global HA submissions. Provide advise to project teams on technical submission requirements. Stay on the pulse of evolving submission related global Health Authority requirements, ensuring NVS is influencing and crafting policy in this area and building strategies to proactively prepare the organization for the future. Continually develop and implement enhanced compliance /process efficiencies to global submission preparation standards, strategies and related procedures/tools. Ensure global cross -functional business/IT/external partners adopt and continually adhere to the established submission/document standards, policies and operating procedures. Lead all aspects of the management and support of all Regulatory Systems and tools, keeping them updated, compliant and validated. Own and ensure a controlled documentation system/record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements/guidances from regulatory agencies. Assures adherence to procedures to classify and maintain records. May analyze and evaluate data, extract pertinent information, prepare abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers May execute people management role, with responsibility for a specific function/technical area. Establishes operational objectives and work plans, and delegates assignments to subordinates. Senior management reviews objectives to determine success of operation. Contributes to and often owns the development of goals and objectives.Minimum requirements What You ll bring to the role: Bachelors or Master s Degree with Team Management skills Proven experience of 10 years and above in the Maintenance Regulatory Function Ability to showcase Strategy Development and Operations Management Demonstrate Execution Project Management Organizational awareness and experience working cross-functionally and in global teams is a plus Excellent written English Communication skills Excellent People management and team leading skillsWhy 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,

Keyskills :
salesbusiness developmentmarketingtargetaccountsteam leadingglobal teamsglobal healthproject teamsteam managementsenior managementpeople managementstrategy developmentcareer opportunities