Novartis hiring for the post of Regulatory CMC – Associate Manager II / Manager (DP/DS)
A global healthcare leader, 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 Title: Regulatory CMC – Associate Manager II / Manager (DP/DS)
Job ID: 189963BR
Job Purpose: Provide and ensure timely preparation of high quality CMC regulatory documentation and support in line with global regulatory submission plans and strategies.
Major Activities:
The following tasks are to be performed as assigned:
- 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 au-thoring issues that may impact submission quality or timelines, as early as possible.
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global re-gions 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.
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Job Dimensions:
Type of Role:
- Technical writer in an individual contributor role with responsibility for global projects.
- No direct reports
Impact on the organization: Contribute to timely global submissions/approvals through high quality documentation and data and adherence to regulatory requirements
Education & Experience (minimum/desirable):
- Post Graduate in Pharmacy or Science (e.g. Chemistry or Biochemistry/Biotechnology) or equivalent
- Minimum 7+ years of experience in core Reg CMC areas
Languages: Fluency in English required (oral and written)
Experience/Professional Requirement:
- Proficient in handling the CMC activities for the various related submis-sions such as INDs/IMPDs/CTAs and/or NDAs/MAAs/ANDAs and/or DMFs/ASMFs/CEPs and associated variations/supplements around the world
- Knowledge/experience of regulations and guidelines associated with the above mentioned submissions
- 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
- 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
- Excellent written/spoken communication and negotiation skills
- Computer literacy
How to Apply:
Interested candidates can apply online via the link below.
