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: Regulatory Manager I/ II/ III - Global Regulatory Affairs
Job Description:
Job Purpose (State in one sentence the overall objective of the role)
Active member of a Regulatory Affairs category team, in charge of the development and execution of regulatory strategies for all regulatory activities in an assigned portfolio of products.
Major Accountabilities (Describe the 5-7 main results of the role to be achieved )
• Responsible for all regulatory matters relating to registrations for assigned product portfolio, for all countries in which the assigned products are or will be registered. Defines the product global registration strategy, to be approved by GRA category head.
• Coordinates and leads Regulatory Expert Teams of Global and Affiliate Regulatory Affairs colleagues to develop and implement regulatory strategies for all countries in product scope. Ensures regulatory priorities of all 4+6 countries in project scope are considered in the project plans and considers impact of including non-priority countries.
• Provides regulatory expert advice to the project team(s) regarding new opportunity evaluations (including due diligence as required) and requirements for product development and life cycle maintenance.
• Member of the extended Category /Brand team, responsible for input into brand strategy and other commercial issues from a regulatory perspective
• May manage European procedures (MRP, DCP, CP) directly or support colleagues who do so.
• Supports regulatory affairs teams in the affiliates for all new registrations and variations to assigned projects and products.
• Supports local RA counterparts in interactions with local Regulatory Agencies and experts. May interact directly with local Regulatory Agencies via email, phone, or in-person meetings, depending on project/affiliate needs
• Interacts with colleagues in other departments, other R&D functions and other Regulatory Affairs functions to deliver customized high quality regions/countries specific dossiers, documents & materials to affiliates in accordance with business priorities.
• Proactively monitors regulatory environment and works with Regulatory Intelligence Team to collect, interpret and distribute relevant information. Maintains a general knowledge of regula-tory requirements for all countries supported.
• May represent Novartis OTC or GRA in various internal or industry teams, trade associations or professional organizations.
• Ensures regulatory compliance by effectively communicating requirements and guidelines, facilitating timely and complete submissions. Applies systems and procedures necessary to maintain proper records and support adequate controls
* May manage a team of regulatory colleagues, depending on the size of the assigned portfolio. If so, responsible for objective setting, performance management, and expertise and career development across regions and product types
• May contribute to special assigned activities and projects within the team or represent GRA in cross-functional assignments & projects.
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Key Performance Indicators (Indicate how performance for this role will be measured)
* Timely submissions and approvals of new products, renewals and variations according to business priorities
* Project Milestone and launch readiness
* Brand performance via launches and resolving regulatory issues
* Quality and compliance metrics for regulatory affairs
* Productivity and process efficiency metrics.
Candidate Profile:
Number of associates: 0 to 5
Financial responsibility: (Budget, Cost, Sales, etc.)
Impact on the organisation: High; effective performance of key accountabilities ensures new registrations and optimized life-cycle maintenance of marketed products.
Education : Graduate or Post Graduate in Pharmacy (e.g.Biotechnology, Pharmacology, Quality] or equivalent
Experience: 5+ to 8+ years in pharmaceutical Regulatory Affairs. Experience in more than one region preferred.
Additional Information:
Experience: 5-8 years
Location: Hyderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 83436BR
End Date: 23rd July, 2011
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