SR REGULATORY AFFAIRS SPEC - SRI LANKA

Job Description

Senior Regulatory Affairs Specialist ??Careers that Change Lives?Make an impact on your community and the lives of others by bringing back the smiles on the faces of human beings suffering from Coronary Vascular disease. Use your passion of sales and relationship building to engage the customers and provide excellent customer service.Lead, mentor and guide a team to drive sales in the northwest region successfully.??A Day in the Life?????????? Proactively work on strategies and registration plan for the whole financial year including new registrations and renewals.????????? Work close with BU on their launch plans and sales forecast so that registration strategies can be aligned.????????? Strong Project management skills????????? Be the face of the RA for the business unit (BU) handled and update the business heads independently????????? Represent RA for the Business unit handled in Monthly and quarterly business review????????? Collaborate and track for whole Business unit with the other team mates handling the sub business of that business unit????????? Proactively access and communicate the policy changes impacting the BU handled and implementing for business continuity????????? Collaborate with supply chain on stock availability according to plan so that there are continuous supplies of the products????????? Work with BU on yearly launch plans and start plan.????????? Keep the active control on labelling and product descriptions for compliance????????? Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in the Indian Sub-Continent (India, Sri Lanka, Bangladesh, Nepal)????????? Coordination with global regulatory teams, local BU and other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.????????? Submit and track registration/re-registration applications with the authorities.????????? Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.????????? Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).????????? Understanding and interpretation of law and the local regulatory requirement and implementing same in submission with compliance.????????? Close monitoring of any changes in local and global regulations and communicating same within the department and respecting and following all SOP / system implemented within the department and organization.????????? Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.? Also ensure continuous implementation of the Quality Management System in India.????????? Supporting the Marketing Teams on Tender related issues??????????Interface and coordinate with regulatory agencies/competent authorities?(CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.??????????Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the Indian Sub-Continent

• Work closely with team team(s) to manage the Regulatory operations activities :
  • Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOPs, archival and systems)?within the department and organization.
  • Effective implementation of corporate/APAC/Local Projects as per timelines and report the progress to management.
  • Support for managing department training.
  • Keeping a track of department tracker, dashboards and report to management.

?Must Have ? Minimum Requirements???????????B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs??????????Must have at least 6-8 years? experience in the pharma/medical device/life science industry with at least 2-3 years medical device experience in regulatory affairs??????????expert with various regulatory requirements for India, Sri Lanka, Bangladesh and Nepal with respect to medical device registration, import, clinical trials, etc.??????????Knowledge and experience in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release??Nice to Have???????????Excellent communication and interpersonal skills - Good verbal communicator and presenter??????????Customer focused:? Understands and delivers customer service??????????Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.??????????Good verbal and written communication skills in English - with colleagues, management and external authorities??????????Self-motivated and positive Can do attitude. Can work autonomously but is also a team player??????????Outgoing and friendly:? Enthusiastic, energetic, diplomatic, willingness to learn??????????Be able to plan, manage, organize and report in an efficient way??????????Be independent, persuasive, innovative and able to summarize??????????Good time management:? Well organized, able to set and reset priorities?PHYSICAL REQUIREMENTS:The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.? Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.??ABOUT MEDTRONICTogether, we can change healthcare worldwide.? At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life.? We challenge ourselves and each other to make tomorrow better than yesterday.? It is what makes this an exciting and rewarding place to be.We can accelerate and advance our ability to create meaningful innovations ? but we will only succeed with the right people on our team.? Let?s work together to address universal healthcare needs and improve patients? lives.? Help us shape the future.??

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