Head - Talent Acquisition at Rashmi Metaliks Limited
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Rashmi Group - Head - Regulatory Affairs - Medical Devices (15-22 yrs)
Rashmi Group - Head - Regulatory Affairs (MEDICAL DISPOSABLE MANUFACTURING)
Experience: 15 + years
Location: Kolkata/Noida
Looking 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 products
Desired 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
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