Job Description
As a Head of Regulatory Affairs, Pharmacovigilance and Quality Assurance, you will represent India in global platform like AAMEO, IO and HQ and you will manage Regulatory Intelligence (legislation and guidelines within the pharmaceutical/healthcare industry) and local regulatory plans by ensuring regulatory approvals, license to operate aligned with local business demands.
As a Head of Regulatory Affairs, Pharmacovigilance and Quality Assurance, you will represent India in global platform like AAMEO, IO and HQ and you will manage Regulatory Intelligence (legislation and guidelines within the pharmaceutical/healthcare industry) and local regulatory plans by ensuring regulatory approvals, license to operate aligned with local business demands.
The Position requires accountability like; Ensure maintenance of RA IT systems used in Novo Nordisk, Influence and Monitor local regulatory environment and ensure compliance, provide regulatory support and insight to external and internal stakeholders, Develop Affiliate level regulatory strategy and Implementation Plans (IPs) and Develop local RA teams.
Additionally, you also manage the local Quality Assurances and related team by ensuring timely completion of affiliate QA activities: documentation systems, Non- conformities and change control repacking, quality plans and QMR, products releases, audits, validation and destructions of safety reporting of observational studies, training and QBIQ administration, QC activities, local records, management business ethical training and documentation, etc.
Candidate Profile
• Post Graduate in Pharmaceutical, Medical Science or related field or relevant business orientation, Advanced degree preferred (PhD, MBA, MDs, MS)
• Advanced knowledge of pertinent local regulations required
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Knowledge of diabetes and diabetes management beneficial, Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
• Fluent in spoken and written English
• Overall minimum of 10 years’ experience with a minimum of 5 years relevant experience required
• Previous supervisory/management experience required depending on team size
• Post Graduate in Pharmaceutical, Medical Science or related field or relevant business orientation, Advanced degree preferred (PhD, MBA, MDs, MS)
• Advanced knowledge of pertinent local regulations required
• Experience with regulatory intelligence activities and pharmaceutical registration databases is preferred
• Knowledge of diabetes and diabetes management beneficial, Knowledge of other therapeutic areas and/or biotech products relevant to Novo Nordisk beneficial
• Fluent in spoken and written English
• Overall minimum of 10 years’ experience with a minimum of 5 years relevant experience required
• Previous supervisory/management experience required depending on team size
Additional Information
Qualification : M.Pharm, M.Sc, PhD, MBA, MDs, MS
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th February, 2019
Qualification : M.Pharm, M.Sc, PhD, MBA, MDs, MS
Location : Karnataka - Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality Assurance
End Date : 10th February, 2019
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