Summary
HA (Health Authority) submissions and regulatory compliances for New Drugs, Line extension, additional indication, production transfer, site registration, renewal, CMC, PI, PSUR to ensure business continuity and support clinical trial projects under GDO and need-based support to other regulatory projects in CPO India. To oversee and drive compliance activities within CPO and ensuring maintenance of the same as per stipulated timeline.
About The Role
Key Responsibilities
- Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products and demonstrate independent working with minimum supervision from manager. Compilation and HA submission of Clinical Trial Application (CTA) dossiers for GDO projects as per defined timelines along with their compliance activities Novartis India Public Affairs for monitoring progress to take next actions steps as appropriate in consultation with RA, GDD Manager/ Head.
- For assigned TAs support in developing and implement regulatory strategy for pipeline products and flawless execution of agreed strategy. Expedite launches for early access & benefits to India patient. Assist managers to design strategies to handle critical applications like legal entity name change of foreign sites, change in Indian agent, warehouse transfers, production transfers, BRS changes etc. to ensure no gap in supplies of essential medicines.
- Maintenance of compliance activities like PSUR, Post approval changes like CMCs and pack insert updates of drug products and their HA submissions. Maintenance of on-going CT projects: Independently, ensure various regulatory compliances related to the clinical trial projects from submission to study completion. Timely review and approval of commercial and clinical applications as and when required.
- Interact with local SSO group for finalization of texts related to clinical trial consignment labels / licenses and ensuring that the same are implemented for timely and smooth clearance of clinical trial materials. Review of protocol, investigator brochure, IMPD documents and entire clinical trial package and co- ordinate with local GDO group to ensure completeness for timely HA submission.
- Responsible for cross-functional coordination (with Legal, Local SSO, Public Affairs) regarding obtaining/ renewal of approvals/licenses as applicable of the CT projects.
- Provide need-based training/information/guidance on regulatory requirements/ updated regulations to associates and stakeholders and as requested by Manager, RA, GDD /Head.
- Independently track, maintain stipulated regulatory requirements /updates regarding the said projects to HA, pre and post submission phase. Assist Head / Manager, RA, GDD for regulatory intelligence; as appropriate.
- People management - Guiding/coaching/mentoring RA Executives and resolving their queries. active participation in cross-functional meetings such as namely Supply Chain Meeting, Global CMC & PIE for impactful collaboration. Co-ordinate with stakeholders for SEC presentations and timely response to HA queries. Process improvements: Proactively identify areas of improvement with regards to local compliance and work closely with CPO DRA colleagues and PIE Leads to address them.
- Ensure maintenance of DRA Regulatory database: May act as DRAGON and CCex Superuser and Single Point of Contact for all CPO DRA compliance activities as assigned by CPO DRA Head. Ensure correct and timely DRA Regulatory database entries e.g. DRAGON, CCex, etc. Audit/inspections: Support the development of DRA related CAPAs to address audit/inspection findings and follow-up on timely closure of the CAPAs.
- Manage deviations and related CAPAs: Oversight of out-of-compliance cases in CPO/cluster, tracking of cases, identification of root causes and solutions. Ensure implementation of corrective action and evaluate effectiveness from time to time. Collaborates with DRA CPO Head and CPO QA to improve efficiency and functionality and maintain CPO compliance.
Minimum Requirements
- A degree in pharmacy, health discipline or life sciences (minimum)
- A post-graduate degree in pharmacy, health discipline or life sciences (desirable).
- Fluent in both written and spoken English
- 3-5y in relevant RA role commensurate with Indian regulatory scenario in multi- national companies
- Experience of working cross-functionally –both local and with HQ/overseas
- Good communication skills
- Inter-personal skills
- Appropriate IT literacy- Microsoft excel, word, PowerPoint, Outlook, Edge etc.
Why Novartis
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-cultureYou’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment To Diversity And Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.Accessibility and accommodationNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.india@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your messageJoin our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:https://talentnetwork.novartis.com/network
Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
