4.0 - 6.0 years

4 - 6 Lacs

hyderabad, telangana, india

On-site

Formulate and lead global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance -Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements. Prepare and communicate CMC Risk Management Assessments, contingency plans, and lessons learned on major submissions and escalate with management as appropriate. Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans. Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators: Produces high quality strategic project documentation and presentations; no late changes in strategy due to inadequate prior evaluation. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate submission documentation on matters within RA CMC control. Delivers reliable, timely and accurate information / communication about project specific issues within own department and to key stakeholders -RA CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines. Provides high quality regulatory evaluation and strategic advice on time (change control, etc.); regulatory compliance met in all compliance systems. Maintains collaborative partnerships with stakeholders. Minimum Requirements: Work Experience: Cross Cultural Experience. Operations Management and Execution. Collaborating across boundaries. Project Management.

Posted 1 week ago

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Relationship Manager, Leading Pvt Bank, Gujarat Phenom Placement Services

3.0 - 7.0 years

0 Lacs

surat, gujarat

On-site

As a Relationship Manager at a Leading Pvt Bank in Gujarat, your primary responsibility will be to increase the Liability book and Investment AUM portfolio size by deepening existing relationships and acquiring new clients. You will be expected to generate revenue through cross-selling business banking and wealth products such as Trade Forex, Insurance, Investments, and Retail Assets. Acquiring Potential Insignia Clients and managing both business and individual (resident and NRI) clients will be key aspects of your role. To ensure client satisfaction and retention, you will need to focus on increasing product penetration, creating exit barriers, and cross-selling multiple products to each client. Regular portfolio allocations, reviews, and financial check-ups for clients are essential to provide tailored wealth management and business banking solutions in collaboration with product specialists. Working closely with Client Experience Managers will be necessary to deliver superior service to clients. Adherence to compliance processes and guidelines is crucial in this role to maintain the quality of documentation and reduce rejection rates. Ensuring 360-degree client engagement and total client ownership are vital for building strong, long-lasting relationships. Your willingness to work from office locations in Vadodara, Ahmedabad, and Surat may be required. If you find this role suitable, please send your CV along with details of your current salary (fixed + variable), expected CTC, current employer (if applicable), current location, notice period, total years of experience in the HNI portfolio, and availability for a face-to-face interview. Best regards, Varsha Phenom Placement Email: Varsha@phenomplacements.in,

Posted 1 month ago

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