This listing was posted on Manatal ATS.
Senior Manager Regulatory Affairs
Location:
Mumbai, Maharashtra
Description:
About the role: Reporting to the Head of Regulatory Affairs, you will be a key member of the team which is responsible for providing strategic and operational regulatory support to project management on new divestment projects, technical transfer, CMOs, quality assurance and commercial departments. Our Regulatory Affairs Department has an ethos of continuous improvement, refining systems and creating efficiencies. This, along with the rapid growth of the business, leads to a varied and dynamic working environment. Main responsibilities duties: Leads the preparation of core dossiers and submissions for global roll out Compile submission documents including M3 dossier sections as necessary, justification documents and Product Information. In collaboration with global partners, consultancies, and distributors, outline global regulatory intelligence and form a global regulatory strategy In collaboration with senior management and project strategy teams, develop and review global cross functional regulatory strategies Ensure diligent reporting and progress updates on regulatory workload at weekly/bi-weekly internal regulatory meeting Interpret applicable regulations and guidelines for project team use; keep project team abreast of regulatory decisions, evolving regulatory requirements, risks and mitigation plans Serve as a primary contact to the local health authority (HA(s), local consultancies/ distributors and internal stakeholders, to ensure timely and accurate submissions Facilitate communication between the HA(s) and the project team; attend and generally lead agency meetings, if required Coordinate and solicit components of the submission from various functional areas, distributors and CMOs Proactively identify project issues to the project team and support mitigation plans Attend cross functional meetings, vendor meetings and kick-off meetings as required Mentor and/or manage other Regulatory Managers, Regulatory Associates and other junior level or administrative Regulatory staff Maintain a high level of professional expertise through familiarity with scientific literature and participation in training courses Other responsibilities may include training employees; planning, assigning, and overseeing regulatory submissions About you: Candidates with at least five years of regulatory generalist experience within a pharmaceutical company, CRO, CMO, or similar organization are likely to have the skills required to be successful in this role. We are also looking for: Bachelors degree in science/health discipline Great IT skills including MS Word, Excel, Project, PowerPoint, and Outlook Expertise in regulatory submission structure and content (e.g., MAA, NDA) Expertise in artwork requirements and review in line with regulations Strong knowledge of EU regulatory framework and guidelines Experience in compliance and maintaining product life cycle databases and RIMs systems Ability to effectively communicate with regulatory authorities Ability to independently present complex regulatory strategies with internal stakeholders and partners Awareness of emerging markets submission rollouts Expertise in writing scientific and technical documents, and strong attention to detail with proofreading materials Excellent time management skills with demonstrated ability to juggle multiple competing tasks and demands Strong organizational skills to establish priorities including scheduling and meeting deadlines Ability to work successfully within cross-functional teams Excellent professional communication skills, both written and verbal Fluent English language (written and verbal) is required, and another language would be an advantage. Please use the below link for job application and quicker response. https://lifelancer.com/jobs/view/ee9542461363915462e83f923de17f46
Company:
Lifelancer
Posted:
April 23 on Manatal ATS
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More About this Listing: Senior Manager Regulatory Affairs
Senior Manager Regulatory Affairs is a Executive Manager Job at Lifelancer located in Mumbai MH. Find other listings like Senior Manager Regulatory Affairs by searching Oodle for Executive Manager Jobs.
Senior Manager Regulatory Affairs is a Executive Manager Job at Lifelancer located in Mumbai MH. Find other listings like Senior Manager Regulatory Affairs by searching Oodle for Executive Manager Jobs.