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Post : Specialist - Regulatory Affairs Manager
Job Description
Your Role
The Specialist, Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.
Position will be working in a matrix organization, with extensive communication and collaboration with stakeholders from various functions within or outside Global Regulatory Affairs. The role will support the resolution of complex tasks, under close supervision and guidance provided from the more experienced License management personnel.
Candidate Profile
• Degree in a Life Science or a related discipline, preferably MSc
• Minimum 5 years of overall work experience in Pharma environment, Competent authority or Academia/R&D experience related to the role. Minimum 1 year of Regulatory affairs experience
• Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or large variations
• Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, International would be an asset)
• Good knowledge about Regulatory Affairs and specifically post approval changes, regulatory dossier types and main regulatory procedures globally
• Understanding of supportive documents necessary for the registration and LCM of pharmaceutical products (CPPs, GMP Certificates, MLs, AtO’s, AFs, CLs, PoA’s etc.) as well as legalization framework
• Ability to review and interpret country specific and international regulatory guidelines, policies and regulations to generate submission ready deliverables as per request
• Adherence to agreed timelines and proactive communication of any potential risk to the same
• Project management and documentation skills, proactive communication approach
• Contributor level of experience with RIM, Vault and EDMS RA applications
• Excellent written and spoken English language
Additional Information
Experience : 5 Years
Qualification : preferably MSc
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
End Date : 30th October 2024
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