Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Senior Professional II with experience in Regulatory Affairs CMC
The position
• As a Senior RA professional main function is to plan, prepare and submit high quality files to the authorities achieving fast approvals for products within the department area of responsibility. You will be responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defined area of responsibility
• Furthermore, you will be responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations.
• This role requires to provide regulatory interaction concerned to scientific issues with affiliates and authorities for all files within the defined area of responsibility and it includes evaluation of the regulatory implications of changes and necessary actions.
• Additionally, you will be responsible CMC part of the Insulin portfolio, Defined standard CMC variation applications (e.g. Additional manufacturing site, extension of product shelf life, new cell banks) and manufacturing site submissions, follow-up and approvals.
Candidate Profile
• Hold M.Pharm degree
• 6 to 8 years of relevant experience in Regulatory Affairs CMC
• Experience within global Regulatory Affairs CMC. Supplemented with experience from related areas in pharmaceutical industry e.g. production, production development or production QA.
• Work experience with European medicines agencies, EMA and with US FDA.
• Require analytical mind set, innovative and customer-oriented skills with the ability to focus on detail without losing the overview
• Focuses on targets and delivering results
• Assesses and solves problems effectively
• Ability to work in teams and to collaborate across functions
• Communicates openly and effectively and negotiates with impact and influence
Additional Information
Qualification : M.Pharm
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs CMC
End Date : 20th July, 2020
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