• Regulatory CMC Manager Jobs in Hyderabad,India

  • Novartis AG
  • Save Job
  • 12 - 15 Years
  • Posted : 27 days ago

Job Description:

Job ID 276225BR

Position Title Regulatory CMC Manager

Job Description Your responsibilities

Your responsibilities include, but are not limited to

1Formulate, lead and drive global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance

2Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate

3Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while applying the global strategy into submissions Make quality regulatory decisions, balancing risks and benefits

4As early as possible, identify the required documentation and any content, quality and/or timeliness issues with them for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines

5Author high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements

6Establish and maintain a single point of contact with FDA or CPOs, DRA regional and TA groups for all communication on development and marketed products Establish and maintain sound working relationships with partners and customers

7Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans

8Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate

9Lead, prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions and escalate to management as appropriate

Minimum requirements What youll bring to the role

Masters Degree in Science or Pharmacy with Minimum 10 years to 12 years of relevant experience in Regulatory Affairs

Working knowledge/experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements

Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects

Regularly demonstrated active contributions to line functions or project teams, as well as ability to contribute to matrix teams with the necessary strategic thinking

Demonstrated ability for strategic thinking, maintaining awareness of business impact Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload

Why consider Novartis

750 million Thats how many lives our products touch And while were proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this how can we continue to improve and extend even more peoples lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment Where youre given opportunities to explore the power of digital and data Where youre empowered to risk failure by taking smart risks, and where youre surrounded by people who share your determination to tackle the worlds toughest medical challenges

We are Novartis Join us and help us reimagine medicine

Division Global Drug Development

Business Unit REG AFFAIRS GDD

Location India

Site Hyderabad, AP

Company/Legal Entity Nov Hltcr Shared Services Ind

Functional Area Research & Development

Job Type Full Time

Employment Type Regular

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Bio Tech/R&D/Scientist
Role : Drug Regulation
Salary : As per Industry Standards
Deadline : 15th Mar 2020

Key Skills:

Company Profile:

Company
Novartis AGarfix

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