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Head - Regulatory Affairs - Medical Devices

15.00 to 22.00 Years   Kolkata   01 Jul, 2022
Rashmi Metaliks Limited
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryCement / Building Material
Functional AreaSBU Head / CEO / Director
EmploymentTypeFull-time

Job Description

    Rashmi Group - Head - Regulatory Affairs (MEDICAL DISPOSABLE MANUFACTURING)Experience: 15 + yearsLocation: Kolkata/NoidaLooking for a resource handled Regulatory Affairs for Manufacturer of Syringe Driver / Syringe Pump / nitrile gloves etc.Responsibilities and main tasks:- Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies- Manage and oversee all relevant maintenance activities potentially including Life Cycle Management strategy- Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications- Provide expert regulatory input to in-licensing evaluations and due diligence activities- Provide advice about regulations to manufacturers/scientists- Coordinate successful submissions and approval of all applications- Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil- Country regulatory and quality standards- Plan, undertake and oversee product trials and regulatory inspections- Keep up-to-date with changes in regulatory legislation and guidelines- Write comprehensible, user-friendly, clear product information leaflets and labels- Liaise and negotiate with regulatory authorities- Develop and establish policies and standards that convey the best practices in the company- Review and report overall quality status to the management team- Project management of development of new generic productsDesired Skills/Experience:- Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance- Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources- Strong initiation and organizational skills- Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes- Strong analytical skill and technical/scientific competence- Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking the big picture view on various options- Team-player, able to positively influence team members at all levels with an entrepreneurial can do attitude- Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion- Experience from working with generics is an advantage- Experience in pharmacovigilance is an advantage,

Keyskills :
high pressure environmentinfluence othershigh pressurequality standardsproject managementregulatory affairsdue diligencelife cyclebig picture viewcreative solutions

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