Executive - Regulatory Affairs

**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
- 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:
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 accommodation

Join 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:
Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Mumbai (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.