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: Regional Regulatory Strategic Associate Director
Job Description:
Job Purpose
Responsible for setting, regulatory strategies and driving the implementation of DRA strat plans for assigned projects in the assigned region. Ensures development and registration milestones of global and regional projects/brands are met, and functional excellence including compliance is achieved. Drives translation of regulatory policy into tangible regulatory strategies for assigned region, including management of external stakeholders. Acts as the program DRA and Project lead for the assigned projects.
Major activities
• Product Registration
- Sets up product development and registration objectives with country DRA teams in alignment with DRA AGL management (Region Head, Sub-Region Heads) and Regional Commercial team objectives in the assigned portfolio and assigned geographic area of responsibility.
- Is accountable for setting optimal regulatory strategy, within the context of the global/regional program, and driving the execution of the strategy in the assigned portfolio and for the assigned geographic area of responsibility during product development and registration phase.
Ensures optimal use of strategic opportunities to ensure acceleration during filing and registration. Participates in Launch Readiness Reviews and provides strategic regulatory input for key markets the assigned portfolio and in the geographic area of responsibility as required.
• Functional Excellence
- Works independently with external and internal stakeholders with minimal supervision.
- Acts as the regional DRA expert to drive regional functional expertise and the implementation of DRA functional excellence activities in the assigned countries of responsibility in line with global/regional DRA guidance/strategy
- Partners with SRH and relevant regional/global stakeholders for the implementation of compliance activities by country DRA teams
- Seeks CPO input and provides strategic guidance to drive/support assigned portfolio and in assigned countries
- Raises contentious issues in a manner that drives resolution, and enables others to do the same
• External Focus
- Represents Novartis in the relevant external HAs to leverage and influence regional regulatory guidelines and standards. Acts as the NVS project lead with assigned external companies.
Project Management:
• Responsible for translation of the RPT / RBT strategy into an optimal development plan and its implementation for one or more programs / brands. Lead all cross-functional discussions to maintain an optimal DRA strat plan (participate in sub-team discussions, critical path analysis, scenario acceleration plans).
• Sound knowledge in project management tools guiding the team(s) to use the right tools in order to come in on time, budget and target.
• Ensures each line function develops and delivers functional plans and execution in a timely manner and to Novartis standards, ensures that line functions are aligned on overall program.
• Leads scenario generation and contingency planning for the integrated plan. Lead all cross-functional discussions to maintain an optimal executional plan (participate in sub-team discussions, critical path analysis, scenario acceleration plans).
• Identify issues, bottlenecks within plan or deviations from plan proactively.
• Able to see a complex program from a "big picture"/strategic level; able to communicate a clear vision for this program and able to set direction for the team and drive teams to decisions.
Key Performance Indicators (Indicate how performance for this role will be measured)
• Proportion of achieved standard and stretch registration milestones/deliverables
• Time to market of new launches with competitive labeling
• Customer satisfaction
• Proof of implementation and sustainability of DRA functional excellence
• Achievement of Regulatory compliance deliverables as per global targets
Job Dimensions (Indicate key facts and figures)
Number of associates: • None. Indirect reports: 0-10
Financial responsibility: (Budget) • Support with budget related activities
Impact on the organization: • Directly impacts time to market and label of products in the assigned region.
• Influence internal and external stakeholders for optimal outcome.
Candidate Profile:
Education (minimum/desirable): Minimum Masters in Life Sciences degree, Advanced degree (MD, Ph.D , or Pharm.D) preferred.Good understanding in business management is desirable.
Languages: Fluent in English (mandatory).
Experience / Professional Requirement:
• Minimum 8-10 experience in drug development and regulatory experience at global, regional or country level
• Ability to work in a cross-functional environment.
• Highly committed and team oriented.
• Excellent communication and negotiation skills in English
• Demonstrated leadership skills.
• Demonstrated ability in planning, problem solving, strategic thinking and time management
• Ability to develop and communicate strategic vision
• Understanding of the pharmaceutical business models in assigned region,
• Shows cultural awareness to work collaboratively with culturally diverse people in global matrix organization
• Ability to continuously adapt and remain well informed and connected within a complex and changing environment
Additional Information:
Experience: 8-10 years
Location: Hyderabad
Education: Pharm.D, M.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 89208BR
End Date: 4th Feb, 2012
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