A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Group Head DRA EM Hyderabad
Job Description:
The Group Head DRA EM Hyderabad provides leadership of the DRA EM Hyderabad team for optimal execution of assigned business deliverables and for development and implementation of the overall strategic vision for Hyderabad DRA EM group.
Major Accountabilities (Describe 8 – 12 main activities)
In collaboration and under supervision of GTAL Regulatory Maintenance & Ex-GBT Brands (DRA EM)
1. Leads planning and execution of assigned Regulatory Maintenance activities for Novartis marketed products portfolio (across Gen Med & Onco).
• Responsible for optimal execution all EU license renewals, EU variations (except CMC-related variations), PSUR submissions for all assigned marketed products with EU regulatory maintenance activities registered via the:
- Centralized Procedure (CP),
- Mutual Recognition Procedure/Decentralized Procedure (MRP/DCP) with the support of the respective Reference Member State (RMS) CPO,
- National Procedure (renewals only).
• Ensures optimal build up of competency and effective transfer of additional activities to Hyderabad team in line with agreed plans in collaboration with and where necessary supervising external consultants and contractors, as appropriate.
2. Ensures proactive global regulatory stewardship including brand optimization and brand defense of assigned Established Medicines portfolio (primary focus on ex-GBT brands i.e. ~60 global brands without formal Global Brand Teams).
• Global Lifecycle Management of assigned EM portfolio including efficient partnering with relevant internal (e.g. CPOs; other global LFs including Global Marketing, BD&L, DRA, Reg–CMC, DS&E) and external stake-holders (e.g. Health Authorities) in creation of regulatory strategies and ex-ecution of action plans to maximize the value of assigned Established Medi-cine brands, world-wide in line with commercial goals and regulatory com-mitments.
- Ensure proactive and efficient communication and prompt and complete responses to regulatory issues/queries from various stakeholders (e.g. HAs, CPOs, BD&L) related to assigned marketed product portfolio, as appropriate.
- Ensure optimal DRA input and collaboration with relevant GLFs, in planning and execution of agreed actions relating to the thorough and efficient management of regulatory procedures across EU, specifically EU referrals and art 45 procedures for assigned EM products.
- Lead and/or supervise DRA input in collaboration with Established Me-dicines Committee (EMC), Global Marketing, BD&L for evaluation and implementation of pruning, in- and out-licensing activities for assigned Established Medicines, world-wide.
3. Provide leadership in establishing an entrepreneurial culture within DRA EM Hyderabad team underpinned by rigorous attention to quality and regulatory compliance
• Participate in multidisciplinary teams (local Hyderabad and global DRA EM) for continuous improvement of internal procedures and management objectives when appropriate.
• Provide training to DRA EM Hyderabad team, representatives of other DRA groups, members of other line functions, on the Novartis Regulatory Maintenance practices and on relevant regulatory requirements or guidelines related to lifecycle management of marketed products.
• Proactively identify regulatory changes and trends that may affect assigned marketed products or development projects, and communicate these changes and their potential impact to management and all internal stakeholders.
• Collaborate with EM DRA and other franchise/ LF stakeholders in identify-ing, communicating and implementing new opportunities for enhanced con-tribution of Hyderabad DRA EM group to business goals in line with fran-chise/LF strategic plans.
• Ensure compliance with all relevant internal SOPs and external regulations.
4. Ensure optimal management of DRA EM Hyderabad team including man-agement of resources.
• Nurture and mentor DRA EM Hyderabad talent to realize full potential in execution of assigned tasks.
- Set objectives for group members, ensure adequate training for as-signed tasks and evaluate the performance of the Global Maintenance Regulatory Managers according to Novartis performance-management process.
• Ensure optimal forecasting, budgeting and monitoring of resource utili-sation for assigned activities.
• Commit to productivity objectives, developing and refining processes, and promoting innovation and external focus.
- Lead continuous evaluation of productivity (Resource Planning Tool) and customer satisfaction (Customer Satisfaction Survey) in relation to defined processes in order to optimise quality and op-erations related to the assigned activities.
Key Performance Indicators (Indicate how performance for this role will be measured)
• Metrics for submissions, approvals, compliance and other regulatory deliv-erables according to the business objectives.
• Quality and timely completion of regulatory documentation, for assigned products and for other assigned initiatives.
• Quality and timely development of regulatory strategies for assigned products and efficient execution of agreed strategies.
• Quality and effectiveness of relationships with Novartis internal and external partners.
• Successful development & retention of DRA EM Hyderabad talents.
Job Dimensions (Indicate key facts and figures)
Number of associates:
Approx. 5-10 regulatory managers (all direct reports) and appropriate administrative support.
Financial responsibility: (Budget, Cost, Sales, etc.)Yes
Impact on the organisation: High:
Responsible for the regulatory maintenance of assigned marketed products portfolio (across Gen Med & Onco) and regulatory stewardship of assigned Established Medicines portfolio (~60 global brands; includes brand optimization and brand defense responsibilities).
Candidate Profile:
Ideal Background (State the preferred education and experience level)
Education (minimum/desirable): PhD or equivalent scientific degree.
Languages: Fluency in English as a business language
Experience/Professional requirement:
1. Advanced regulatory affairs and/or drug development knowledge with proven regulatory strategic leadership and experience of interacting with major HA's worldwide.
2. Strong leadership and proven people management skills including evidence of enabling superior team performance.
3. Excellent interpersonal, communication and negotiation skills, and proven ability to work and lead effectively in a matrix/ multicultural/multidisciplinary environment.
4. Entrepreneurial approach with a strong quality and compliance ethos - ability to spearhead creation and execution of regulatory strategies to maximize the value of assigned Established Medicine brands, world-wide in line with commercial goals and regulatory commitments.
Additional Information:
Experience: 1-4 years
Location: Hyderabad
Education: Ph.D
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 78583BR
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