Regulatory CMC Associate Manager Job Opening @ Novartis
Novartis Pharma Manager. Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job Title: Regulatory CMC Associate Manager-II
Job Id: 276976BR
Eligibility: Masters Degree in Science or Pharmacy with Minimum 3 years to 5 years of relevant experience in Regulatory Affairs
Experience:
- 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
Job Description
Your responsibilities include, but are not limited to:
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle.
- Prepare CMC responses to health authority questions during development, registration and product lifecycle.
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
