12 April, 2022
200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
Your responsibilities include but not are limited to:
- Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.
- Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies.
- Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions.
- Serves as a regulatory liaison on the project team throughout the product lifecycle.
- Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices.
- Serves as regulatory representative to marketing or research project teams and government regulatory agencies.
- Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
- Coordinates, reviews, and may prepare reports for submission.
- Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partners with regions to align on regulatory strategy in order to fulfil business objectives
- Implements RFP across assigned regions.
- Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
- Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
- Develops and implements plans for timely response to HA requests and coordinates responses.
- May serve as local HA liaison depending on location (e.g., FDA or EMA).
- Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
- Review of global dossier summary documents.
- Develops and implements plans to avoid/minimize clock stops during submission review.
- Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Reviews and submits Risk Management Plans.
- May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
- Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
- Contributes to and often leads the development of departmental goals and objectives.
- For assigned TAs, develop regulatory strategy for pipeline products and ensure flawless execution of strategy.
- Build strong network externally, with state FDA, CDSCO offices and participation in industry meetings as needed.
- People Management responsibility including development and coaching of direct reports.
- Oversee all regulatory compliance related to assigned TAs.
- F-u with Head Public Affairs to monitor progress of review/ approval
- Ensure collaborative working relationship with internal cross functional stakeholders
- Review and approval of promotional material
- Leadership initiatives, Simplification of procedures, coaching of RA ex/ Sr ex, Co-ordinate for impactful SEC meetings, Timely responses to HA queries, Keep abreast of newer reg guidelines and impact assessment
- Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
- Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards.
- Successful Participation in HA interactions to achieve business objectives.
- Adherence to Novartis policy and guidelines -Project & stakeholder feedback
- Stakeholder Engagement, Operations Management and Execution Project Management Representing the organization Functional Breadth Cross Cultural Experience.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
- Regulatory Strategy 10+ years of relevant experience in Data Science
- Post graduate in Pharmacy, health discipline, life science, science.
- 10-12 years’ experience in Pharma Industry with relevant fields
This role is critical in terms of seeking early regulatory approval for our priority pipeline products
This higher or expanded responsibility for Sr manager is important for RA function
Interested folks can submit their resume to – firstname.lastname@example.org