Novartis Pharma Executive Vacancy 2021 – Apply Online
Novartis invited candidates with an MSc chemical science degree for the post of Executive Executive– RA GDD. Pharma job opening 2021. Pharma job 2021. Candidates with an undergraduate degree in pharmacy may apply for the job opening at Novartis. Check out all the details on the same below:
Job Title Executive– RA GDD
Job ID 322941BR
Your responsibilities include but not are limited to:
• Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
• Ensures compliance to the requirements from regulatory agencies.
• Maintains the technical and non-technical documentation change system.
• Assures procedures are in place to classify and maintain records.
• Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements.
• May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers.
• May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched.
• May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to
the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Write, edit and /or manage the production of high quality clinical documentation (e.g. Clinical Study Reports & Summary Documents) for submission to regulatory authorities in support of marketing applications.
• Developing professional expertise, applies company policies & procedures to resolve a variety of issues. .
• Frequent internal company and external contacts.
• Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Refers to established policies & procedures for guidance.
• Contributes to some cost center goals & objectives Assist Head RA, GDD /Manager for regulatory intelligence; as appropriate.
• Compilation and HA submissions of New Drug applications, Line extensions, additional indications along with the site registrations, renewals and production transfer applications for Novartis Pharma products.
• Compilation and HA submission of Clinical Trial Application (CTA) dossiers for GDO projects as per defined timelines along with their compliance activities Novartis India Public Affairs for monitoring progress to take next actions steps as appropriate in consultation with RA, GDD Manager/ Head.
• Maintenance of compliance activities like PSUR, Post approval changes like CMCs of imported products and their HA submissions.
• Maintenance of on-going CT projects: Independently, ensure various regulatory compliances related to the clinical trial projects from submission to study completion.
• Interact with local GDO group for finalization of texts related to clinical trial consignment labels / licenses and ensuring that the same are implemented for timely and smooth clearance of clinical trial materials.
• Review of protocol, investigator brochure, IMPD documents and entire clinical trial package and coordinate with local GDO group to ensure completeness for timely HA submission.
• Responsible for cross-functional coordination (with Legal, Local GDO group, Public Affairs) regarding obtaining/renewal of approvals/licenses as applicable of the CT projects.
• Develop and maintain good working relations
Minimum Requirements
• Education:- (Minimum) Must have – Bachelor’s degree in any specialization. (Desirable) – A degree in pharmacy, health discipline or life sciences (minimum) A post-graduate degree in pharmacy, health discipline or life sciences (desirable).
• Adherence to Novartis policy and guidelines -Project & stakeholder feedback
• Operations Management and Execution Project Management Collaborating across boundaries Functional Breadth Cross-Cultural Experience
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