RA CMC Manager

Novartis India

Hyderabad

On-site

INR 900,000 - 1,500,000

Full time

14 days+

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Job summary

A leading global pharmaceutical company in Hyderabad is seeking an experienced RA CMC Manager to oversee regulatory activities related to chemistry, manufacturing, and control (CMC). The role involves leading the global regulatory strategy and ensuring compliance with health authority guidelines. Ideal candidates will have strong project management and negotiation skills, along with a deep understanding of CMC documentation and processes.

Qualifications

Experience in regulatory activities related to chemistry, manufacturing, and control (CMC).
Ability to prepare high-quality CMC documentation.
Strong negotiation and risk management skills.

Responsibilities

Lead global CMC regulatory strategy and submission activities.
Ensure compliance with regulatory guidelines.
Prepare and communicate CMC Risk Management Assessments.
Author/review high-quality CMC documentation for Health Authority submissions; ensure regulatory compliance and timely e-publishing.
Initiate and lead Health Authority interactions; prepare briefing books and risk mitigation plans.

Skills

Cross Cultural Experience

Operations Management

Collaborating across boundaries

Project Management

Change Control

Cross-Functional Teams

Documentation Management

Negotiation Skills

Regulatory Compliance

Risk Assessment

Risk Management

Job description

Join to apply for the RA CMC Manager role at Novartis India

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 HA's on REG CMC questions to support new product or post marketed launches.

Summary

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 HA's on REG CMC questions to support new product or post marketed launches.

About The Role

Major accountabilities:

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.

Skills

Change Control.
Cross-Functional Teams.
Documentation Management.
Negotiation Skills.
Project Management.
Regulatory Compliance.
Risk Assessment.
Risk Management.

Languages

English.

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