Pharma & Chemistry Job : Regulatory Associate Manager Position @ Novartis

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Novartis

Job Title  Regulatory CMC Associate Manager-II

Job Description:

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. 3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 4. 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. 5. Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends. 6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. 7. 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).  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. 3. Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. 4. 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. 5. Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends. 6. Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned. 7. 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). Manage daily operation and complete the task as per require TAT Master Degree English Relavant Experience in Slotted Dev & Med

Qualifications Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or eq Fluent English required (oral and written). Good skills in site (local) language desired (oral) 1. 2-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals 2. Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines. 3. Demonstrated track record to successfully work in interdisciplinary teams, planning, coordinating, leading activities simultaneously on multiple projects. 4. Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable. 5. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload. 6. Effective planning, organizational and interpersonal skills. 7. Reasonable approach to risk assessment. 8. Excellent written/spoken communication and negotiation skills. 9. Computer literacy.

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