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License & Sample Manager

10 - 15 yrs
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Not Disclosed by Recruiter Openings: 1 Posted 30+ days ago Job Applicants: 75 Job Views: 861

Job Description

 
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    Position Purpose

    Lead, manage and be accountable for providing regulatory guidance and driving creation of documentation and liaison with regulatory authorities for obtaining for drug licenses approval/ post approval activities and query resolution. Establish and maintain successful relationships with local government officials and other key stakeholders for obtaining state excise license and narcotic license for con- trolled substance in a timely manner to meet the project timelines. Also accountable for maintaining and updating material life cycle from receipt to distractions.

    Major Accountabilities

    1.Manage day to day operations of material inventory and transport across SDC India including drug sub- stance, drug product, packaging material, and excipients, Medical devices 2.Optimize shipment lead times of the above 3.Coordinate with shippers (internal and external) to ensure smooth transport of materials (e.g. invoice management, import license coordination) 4.Maintain close communication with shippers and custom agents to ensure proper handling of samples 5.Manage import/ export permits of pharmaceuticals drug substance, drug product, excipients 6.Coordinate activities with Sourcing and Finance to ensure smooth material management operations 7.Author high- quality regulatory documentation for state DCA and CDSCO drug license submission, applying Indian regulatory strategies as per the applicable drug laws, assuring technical and regulatory compliance, meeting agreed upon timelines and meeting requirements throughout project lifecycle. 8.Identify the required documentation for regulatory applications and negotiate with the regulatory authorities and internal stakeholders to ensure availability of valid drug licenses in accordance with project timelines. 9.Translate the required source documentation into regulatory application documentation, identifying any content, quality and/ or timeliness issues. 10.Contribute to defining the regulatory strategy, identifying the critical issues and sharing lessons learned. 11.Facilitate consistency within the regulatory documentation by sharing experience and/ or contributing to template maintenance 12.Coordinate and collaborate with the intellectual property team and project patent attorney and legal and compliance team to get approval on the product in- formation disclosed in the regulatory applications 13.Keep a track of the regulatory updates and appraise all the stakeholders and ensure timely implementation 14.Regular updates of regulatory compliance records. 15. Accountable and end- to- end responsibility for material receipt to destruction. 16.Provide efficient procedures and processes for the maintaining of license. 17.Coordination with line function and support functions. 18.Coordination with internal/ external vendor and regulatory agencies.

    Key Performance Indicator

    1.Adherence to costs, quality, quantity, and timelines for all assigned tasks. 2.Adherence to Novartis standards, in particular, quality, ethical, health, safety, and environment (HSE) , and information security (ISEC) standards. 3.Adherence to all the legal requirements as per Novartis/ Sandoz Standards. 4.Feedback from other team members/ leaders

    Why consider Novartis Group of Companies 927 million. That s how many lives our products touched in 2017. And while we re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s livesWe believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

    We are Novartis group of companies. Join us and help reimagine medicine

    Minimum requirements

    Minimum: Masters/ Bachelor degree in pharmaceutical science or equivalent Good knowledge of English (oral and written) . Desirable knowledge of site language 1.Successfully demonstrated several years (mini- mum of 10 years) of directly related experience as R &D lab operation. 2.Recognized expertise in a specific area. 3.Ability to work in and/ or lead interdisciplinary and/ or cross- cultural teams. 4.Strong knowledge on legal requirements for import and Export of materials and Novartis regulations and policies. 5.Strong communication skills. Strong presentation skills and scientific/ technical writing skills. Advanced coaching skills. 6.May require up to 10% travel

    Division

    SANDOZ

    Business Unit

    Product Dev SZ

    Country

    India

    Work Location

    Hyderabad, AP

    Company/ Legal Entity

    Nov Hltcr Shared Services Ind

    Functional Area

    Research & Development

    Job Type

    Full Time

    Employment Type

    Regular

Salary: Not Disclosed by Recruiter

Industry: Pharma, Biotech, Clinical Research

Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:Medical Professional

Role:Administration Services/Medical Facilities

Employment Type: Full Time, Permanent

Keyskills

Education-

UG: Any Graduate - Any Specialization

PG:Post Graduation Not Required

Company Profile:

Novartis Healthcare Pvt. Ltd.

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 us one of the most rewarding employers in our field.
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