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: Manager Drug Regulatory Affairs
Job Description:
Responsible for managing OTC BU’s regulatory approvals and Pharmacovigilance. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority innovations & programs.
MAJOR ACCOUNTABILITIES:
• Direct the preparation and presentation of all necessary regulatory documentation for the BU, through active outreach to BU and regional medical and CRA personnel.
• Develop regulatory-outreach plans working closely with other CRA and Market Access personnel to ensure efficient approval of in-country products and programs
• Allocate DRA personnel and resources to provide necessary documentation and support for high-priority compounds and products
• Ensure clear communication channels between BU Regulatory Affairs personnel and global and regional Development, CRA, and Market Access officers
• Key interfaces include: Marketing, QA, Pharmacovigilance
• Prepare and submit new licence applications within agreed timeframes
• Monitor and influence license progress to expedite and optimise the outcome and from licence grant, on, ensures the continuing validity of the way the licence is used throughout the product life-cycle
• Contribute to maintenance of various forms of labelling e.g. provides Basic Product Information (BPI)
• New Product Registrations – evaluate, prepare and submit drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome
• Maintenance of registered products – maintain registration of currently approved products
• Product Information and Consumer Information – develop and maintain product information and consumer information ensuring the correct distribution and use of the approved versions of these documents
• Review of Promotional Material – Review promotional material for assigned products in line with OTC P3 and Global / local DRA framework and Global Medical Affairs
• Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with health authority and industry bodies, such as the APMA. Provide valuable regulatory advice as necessary.
• Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible
• Develop convincing dossiers for new OTC / Ayurvedic products & obtain DCGI / local FDA approvals for marketing authorization.
• Pharmacovigilance:
o Carry out Pharmacovigilance activities related to OTC products while adhering to Global OTC Guidelines. Network with Global stakeholders in this regard.
o Plan, direct and control the drug safety/pharmacovigilance function in order to meet national and international regulatory requirements, including safety surveillance, drug safety strategy, representation and communication with regulatory authorities. Ensure integration of these requirements into the organisation’s general documentation and registration process.
o Is responsible for drug safety / pharmacovigilance throughout the entire product lifecycle (from drug development, through clinical trials to postmarketing surveillance).
o Has overall control of all drug safety and pharmacovigilance activities in a company operating primarily, though not exclusively on the local market.
o Responsible for planning, development, maintenance and monitoring of drugs quality, safety and efficiencies. Implements reporting systems that comply with national and international legal requirements and guidelines.
KEY PERFORMANCE INDICATORS:
Financial and Business Results:
• Time to peak sales for products across the BU portfolio
• Licence applications are prepared to agreed timelines and quality
• The timely registration of new drug products
• Accurate maintenance of new registrations
Strategy/Market Focus:
• Novartis reputation with regulators: surveys, interviews, polls, media
• Regional/global coordination: alignment with regional/global strategies, best-practice import/export, Pharma forum participation
Operational Excellence:
• Product launch success: product milestones, time to peak sales
• Time to market for products across the BU portfolio
• Efficiency and success rate of regulatory submissions
• Satisfaction of internal customers with quality and appropriateness of information/reports provided by RA
Candidate Profile:
• University degree in Pharmacy / Bio Sciences
• Advanced degree in bioscience or medicine
• Significant (7-10 years) experience in clinical regulation and management of clinical approval processes
• Experience and adequate Knowledge of pharmacovigilence
• Clear and full understanding of relevant pharmaceutical regulation and approval processes
• Ability to engage regulators in trust-based scientific discourse
• Excellent oral and written communication skills
• Strong presentation skills
• Ability to lead and develop other scientific and professional reports
• Clinical research and publication experience preferred
Additional Information:
Experience: min. 7 years
Location: Hyderabad
Education: M.Pharm, M.Sc, B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Development & Medical
Division: Over The Counter
Business Unit: NCH
Job Type: Full Time
Employment Type: Permanent
Job ID: 76639BR
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