Company: Novartis India Limited
Location: Mumbai
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
- Process management Working experience within the pharmaceutical industry Technical knowledge Regulations & Guidelines Health Authorities Regulatory Submissions Regulatory Compliance 2+ years of relevant experience in RA (regulatory Affairs).
Roles & Responsibilities:
- Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
- Ensures compliance with the requirements of 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 maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
- Manages medium to small level global regulatory submission projects.
- 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.
- 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
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