Rashmi Group - Head - Regulatory Affairs - Medical Devices

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