Novartis Pharma Job Vacancy – Pharma & Chemistry CMC Manager
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Job ID 283935BR
Job Title Associate Manager II, Regulatory CMC
Eligibility:
What you’ll bring to the role:
Degree in Science (e.g. Chemistry, Pharmacy) or equivalent Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
- Fluent English required (oral and written).
- Good skills in site (local) language desired (oral)
- Minimum 4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or phar-maceutical technology. Knowledge of the drug development pro-cess desirable.
- Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Effective planning, organizational and interpersonal skills.
- Reasonable approach to risk assessment.
Job Description
The Associate Manager, Reg CMC will broadly be
1. 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.
2. Prepare CMC responses to health authority questions during development, reg-istration and product lifecycle.
Your responsibilities:
Your responsibilities include, but are not limited to:
- 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.
- Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
- Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
- Establish and maintain sound working relationships with partners and customers. 8. Assume activities in support of the general department such as DRAGON sup-port, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database en-try activities (specialized department functions).
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