Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Reg CMC Manager
Job Description
1.Formulate and lead 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
2.Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to in-terdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate.
3.Lead and implement all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products, while ap-plying the global strategy into submissions. Make quality regulatory decisions, balancing risks and benefits.
4.As 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.
5.Author 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.
6.Establish 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.
7.Initiate and lead Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning re-hearsals and risk mitigation plans.
8.Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, and prepare CMC responses, as appropriate.
9.Prepare and communicate CMC dossier risk analyses (SWOTS), contingency plans and Lessons Learned on major submissions with subteams and escalate with management as appropriate.
10.Keep knowledge up to date with regard to regulatory guidelines and require-ments in all global regions as well as for new technical trends.
11.Assume specialized assignments as assigned and represent Reg CMC in cross functional project teams.
12.Represent REG CMC at Global Supply Support Teams (SST), Regulatory review boards and other teams and boards as appropriate.
Minimum requirements
Education (minimum/desirable):Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desirable: advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
Languages:Fluent English required (oral and written). Good skills in site (local) language desired (oral)
Experience/Professional requirement:
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.
Additional Information:
Job ID: 204645BR
Experience: 2-4 years
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 25th Octo, 2017
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