RA CMC Manager

NOVARTIS

6 - 11 years

8 - 13 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

biotechnology networking pharma project management risk assessment diversity and inclusion regulatory compliance cmc risk management recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HAs on REG CMC questions to support new product or post marketed launches.

About the Role

Key responsibilities

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)

Essential requirements

Drug product experience is mandatory,
Operations Management and Execution.
Collaborating across boundaries.
Project Management.
Change Control.
Documentation Management.
Negotiation Skills, Project Management, Regulatory Compliance.
Risk Assessment
pharmaceutical or biotech organizations

Desirable requirement

Prior experience working in pharmaceutical or biotech organizations

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