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: Regulatory CMC Associate Manager-II / Manager (DP/DS)
Job Description:
The following tasks are to be performed as assigned:
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).
Candidate Profile:
Post Graduate in Pharmacy or Science (e.g. Chemistry or Biochemistry/Biotechnology) or equivalent Minimum 7+ years of experience in core Reg CMC areas
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1.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
2. Knowledge/experience of regulations and guidelines associated with the above mentioned submissions
3.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
4. Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
5. Effective planning, organizational and interpersonal skills
6. Reasonable approach to risk assessment
7. Excellent written/spoken communication and negotiation skills
8. Computer literacy
Additional Information:
Experience: 7+ years
Location: Hyderabad
Education: M.Pharm, M.Sc, Chemistry, Biochemistry, Biotechnology, Biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Human Resources
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 189963BR
End Date: 15th July, 2016
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