Manager, Regulatory CMC

☞ Novartis

View: 107

Update day: 06-05-2024

Location: Hyderabad / Secunderabad Telangana

Category: Legal / Contracts Production / Operation Pharmacist / Pharmaceutical representatives Printing / Publishing

Industry: Healthcare

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Job content

582! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in patients’ lives and we need your help. As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for our products covering development and post-approval activities. You bring a foundation of regulatory knowledge and a collaborative and patient-focused mindset

Your Responsibilities:

Your responsibilities include but not are limited to:

  • Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and 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.

  • 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.

  • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams as appropriate.

  • 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.

Minimum requirements

What You’ll bring to the role :

  • University or College Degree in any field or life science with relevant industry experience or comparable degree.

  • At a minimum 7 years’ experience in the Pharmaceutical area, specifically in Regulatory Operations

  • Good communication in English (oral and written).

  • Knowledge of Regulatory guidelines for the areas mentioned above

  • Organizational awareness and experience working cross-functionally and in global teams is a plus

  • Ability to work under pressure, demonstrating initiative and flexibility

  • Attention to detail and quality focused

  • Team-minded

WHY NOVARTIS?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Division

Global Drug Development

Business Unit

REG AFFAIRS GDD

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

Shift Work

No
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Deadline: 20-06-2024

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